75 Regulatory Compliance jobs in India

Regulatory Compliance

Mumbai, Maharashtra Abbott

Posted 12 days ago

Job Viewed

Tap Again To Close

Job Description

**Primary** **Job** **Function:**
To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.
**Core Job Responsibilities:**
**Regulatory Submissions and compliance**
+ Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
+ Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
+ Ensure timely submissions and approvals for all regulatory filings.
+ Evaluate technical and scientific data for regulatory submissions.
+ Liaise with health authorities for inspections, clarifications, and approvals.
+ Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
**Product & Business Support**
+ Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
+ Provide regulatory support for internalization and externalization of products.
+ To provide site CMC documents to international business team to support export registration.
**Documentation & Quality Oversight**
+ Maintain and update regulatory databases, trackers, licenses, and approvals.
+ Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
+ Evaluate and approve site change controls and Change Request evaluation forms.
+ Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
**Tender Certificates**
+ To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
+ Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
**Governance, SOPs & Training**
+ Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
+ Deliver training on GMP, regulatory updates, and SOPs at the site level.
+ Approve SCNs from Corporate QA and review reports from regulatory authorities.
**Additional Responsibilities**
+ Complete assigned trainings on time
+ Perform other duties as assigned by the Regulatory Affairs leadership.
+ Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
**Position Accountability/Scope:**
+ ·Responsible for all regulatory activities for the manufacturing site mainly LL sites.
+ ·Ensures site compliance with applicable national regulations and Abbott standards.
+ Supports business continuity through proactive regulatory planning and execution.
**Minimum Education:**
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
**Minimum Experience/Training Required:**
+ **Manager:** Minimum 08 - 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
+ Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.

Regulatory Compliance

Mumbai, Maharashtra Abbott

Posted today

Job Viewed

Tap Again To Close

Job Description

Primary Job Function:

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

Core Job Responsibilities:

Regulatory Submissions and compliance
  • Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
  • Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
  • Ensure timely submissions and approvals for all regulatory filings.
  • Evaluate technical and scientific data for regulatory submissions.
  • Liaise with health authorities for inspections, clarifications, and approvals.
  • Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
  • Product & Business Support
  • Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
  • Provide regulatory support for internalization and externalization of products.
  • To provide site CMC documents to international business team to support export registration.
  • Documentation & Quality Oversight
  • Maintain and update regulatory databases, trackers, licenses, and approvals.
  • Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
  • Evaluate and approve site change controls and Change Request evaluation forms.
  • Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
  • Tender Certificates
  • To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
  • Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
  • Governance, SOPs & Training
  • Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
  • Deliver training on GMP, regulatory updates, and SOPs at the site level.
  • Approve SCNs from Corporate QA and review reports from regulatory authorities.
  • Additional Responsibilities
  • Complete assigned trainings on time
  • Perform other duties as assigned by the Regulatory Affairs leadership.
  • Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
  • Position Accountability/Scope:

  • ·Responsible for all regulatory activities for the manufacturing site mainly LL sites.
  • ·Ensures site compliance with applicable national regulations and Abbott standards.
  • Supports business continuity through proactive regulatory planning and execution.
  • Minimum Education:

    B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

    Minimum Experience/Training Required:

  • Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
  • Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
  • This advertiser has chosen not to accept applicants from your region.

    Regulatory Compliance

    Noida, Uttar Pradesh Corpseed ITES Private Limited.

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    Job Description:

    - Serves Clients by advising services and meeting customer needs.
    - Experience - 3 + years of experience in Same industry
    - Extensive Knowledge about BIS Verticals.
    - Establish, develop and maintain positive business and client relationships
    - Extensive and experienced knowledge about Bureau of Indian Standard (ISI, FMCS, CRS)

    Qualifications/Skills:Customer service
    Prospecting skills
    Self-confidence
    Product knowledge
    Presentation skills
    Client relationships
    Should have proper knowledge about Bureau of Indian Standard (ISI, FMCS, CRS)

    **Job Types**: Full-time, Regular / Permanent

    **Salary**: ₹18,000.00 - ₹40,000.00 per month

    **Benefits**:

    - Cell phone reimbursement
    - Health insurance
    - Provident Fund

    Schedule:

    - Day shift

    Supplemental pay types:

    - Performance bonus
    - Yearly bonus

    Ability to commute/relocate:

    - Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)

    Application Question(s):

    - What is your current inhand salary?

    **Experience**:

    - total work: 1 year (required)
    This advertiser has chosen not to accept applicants from your region.

    RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

    Hyderabad, Andhra Pradesh EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Review status updates and prepare management presentations.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Contribute to performance feedback for staff
  • Foster teamwork and a positive learning culture
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Prior experience of leading quality and compliance projects in Regulatory Compliance.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Hands on experience of preparing validation deliverables for software implementation projects
  • Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
  • Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Demonstrated track record in project management, governance, and reporting
  • Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
  • Exposure to Data Integrity requirements and other applicable regulations
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
  • Prior experience of supporting Audits / Inspections
  • To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.

    RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

    Noida, Uttar Pradesh EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Review status updates and prepare management presentations.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Contribute to performance feedback for staff
  • Foster teamwork and a positive learning culture
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Prior experience of leading quality and compliance projects in Regulatory Compliance.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Hands on experience of preparing validation deliverables for software implementation projects
  • Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
  • Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Demonstrated track record in project management, governance, and reporting
  • Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
  • Exposure to Data Integrity requirements and other applicable regulations
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
  • Prior experience of supporting Audits / Inspections
  • To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.

    RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

    Bengaluru, Karnataka EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Review status updates and prepare management presentations.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Contribute to performance feedback for staff
  • Foster teamwork and a positive learning culture
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Prior experience of leading quality and compliance projects in Regulatory Compliance.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Hands on experience of preparing validation deliverables for software implementation projects
  • Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
  • Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Demonstrated track record in project management, governance, and reporting
  • Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
  • Exposure to Data Integrity requirements and other applicable regulations
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
  • Prior experience of supporting Audits / Inspections
  • To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.

    RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

    Chennai, Tamil Nadu EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Review status updates and prepare management presentations.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Contribute to performance feedback for staff
  • Foster teamwork and a positive learning culture
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Prior experience of leading quality and compliance projects in Regulatory Compliance.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Hands on experience of preparing validation deliverables for software implementation projects
  • Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11
  • Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
  • Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Demonstrated track record in project management, governance, and reporting
  • Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
  • Exposure to Data Integrity requirements and other applicable regulations
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
  • Prior experience of supporting Audits / Inspections
  • To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for yo
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.
    Be The First To Know

    About the latest Regulatory compliance Jobs in India !

    RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager

    Kochi, Kerala EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Identify opportunities in existing accounts to cross-sell other EY services.
  • Planning and monitoring of the project deliverables from the team.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Demonstrate flexibility to travel to the customer locations on need basis
  • Conduct performance reviews and contribute to performance feedback for staff and senior staff
  • Foster teamwork, quality culture and lead by example
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Participate in the organization-wide initiatives
  • Lead practice initiatives and portfolios
  • Market trend +Digital trends.
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Has worked in executing the Validation Deliverables in software implementation projects
  • Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization.
  • Versed with SOP documentation, analysing the work instructions, user manuals
  • Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems
  • Strong understanding of Data Integrity requirements
  • Governance and reporting
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
  • Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Has supported Audits / Inspections
  • To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
  • Experience in managing team and solution designing
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • Project Management
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

    Support, coaching and feedback from some of the most engaging colleagues around

    Opportunities to develop new skills and progress your career

    The freedom and flexibility to handle your role in a way that’s right for you

    About EY

    As a global leader in Assurance, Tax, Strategy & transactions and Consulting services, we’re using the finance products, expertise and systems we’ve developed to build a better working world. That starts with a culture that believes in giving you the training, opportunities and creative freedom to make things better. Whenever you join, however long you stay, the exceptional EY experience lasts a lifetime. And with a commitment to hiring and developing the most passionate people, we’ll make our ambition to be the best employer by 2020 a reality.

    This advertiser has chosen not to accept applicants from your region.

    RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager

    Chennai, Tamil Nadu EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Identify opportunities in existing accounts to cross-sell other EY services.
  • Planning and monitoring of the project deliverables from the team.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Demonstrate flexibility to travel to the customer locations on need basis
  • Conduct performance reviews and contribute to performance feedback for staff and senior staff
  • Foster teamwork, quality culture and lead by example
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Participate in the organization-wide initiatives
  • Lead practice initiatives and portfolios
  • Market trend +Digital trends.
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Has worked in executing the Validation Deliverables in software implementation projects
  • Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization.
  • Versed with SOP documentation, analysing the work instructions, user manuals
  • Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems
  • Strong understanding of Data Integrity requirements
  • Governance and reporting
  • Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
  • Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
  • Has supported Audits / Inspections
  • T o qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
  • Experience in managing team and solution designing
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • Project Management
  • What we look for

  • A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
  • An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
  • Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
  • What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.

    RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager

    Kolkata, West Bengal EY

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    The opportunity

    We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

    Your key responsibilities

  • Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
  • Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
  • Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
  • Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
  • Identify opportunities in existing accounts to cross-sell other EY services.
  • Planning and monitoring of the project deliverables from the team.
  • Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
  • Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
  • Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.
  • Actively contribute to improving operational efficiency on projects & internal initiatives.
  • Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
  • Demonstrate flexibility to travel to the customer locations on need basis
  • Conduct performance reviews and contribute to performance feedback for staff and senior staff
  • Foster teamwork, quality culture and lead by example
  • Understand and follow workplace policies and procedures
  • Training and mentoring of project resources
  • Participate in the organization-wide initiatives
  • Lead practice initiatives and portfolios
  • Market trend +Digital trends.
  • Cross skill and cross train the team members as per the business requirements
  • Skills and attributes for success

  • Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
  • Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance
  • Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
  • Has worked in executing the Validation Deliverables in software implementation projects
  • Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
  • Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
  • Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization.
  • Versed with SOP documentation, analysing the work instructions, user manuals
  • Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems
  • Strong understanding of Data Integrity requirements
  • Governance and reporting

    Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.

    Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.

    Has supported Audits / Inspections

    To qualify for the role, you must have

  • (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies
  • Good interpersonal skills; Good written and presentational skills
  • At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
  • Experience in managing team and solution designing
  • Ideally, you’ll also have

  • Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
  • ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
  • Information Security or Risk Management certifications
  • Project Management
  • What we look for

    A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.

    An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.

    Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

    What working at EY offers

    At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

    You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

  • Support, coaching and feedback from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • EY | Building a better working world 

    This advertiser has chosen not to accept applicants from your region.
     

    Nearby Locations

    Other Jobs Near Me

    Industry

    1. request_quote Accounting
    2. work Administrative
    3. eco Agriculture Forestry
    4. smart_toy AI & Emerging Technologies
    5. school Apprenticeships & Trainee
    6. apartment Architecture
    7. palette Arts & Entertainment
    8. directions_car Automotive
    9. flight_takeoff Aviation
    10. account_balance Banking & Finance
    11. local_florist Beauty & Wellness
    12. restaurant Catering
    13. volunteer_activism Charity & Voluntary
    14. science Chemical Engineering
    15. child_friendly Childcare
    16. foundation Civil Engineering
    17. clean_hands Cleaning & Sanitation
    18. diversity_3 Community & Social Care
    19. construction Construction
    20. brush Creative & Digital
    21. currency_bitcoin Crypto & Blockchain
    22. support_agent Customer Service & Helpdesk
    23. medical_services Dental
    24. medical_services Driving & Transport
    25. medical_services E Commerce & Social Media
    26. school Education & Teaching
    27. electrical_services Electrical Engineering
    28. bolt Energy
    29. local_mall Fmcg
    30. gavel Government & Non Profit
    31. emoji_events Graduate
    32. health_and_safety Healthcare
    33. beach_access Hospitality & Tourism
    34. groups Human Resources
    35. precision_manufacturing Industrial Engineering
    36. security Information Security
    37. handyman Installation & Maintenance
    38. policy Insurance
    39. code IT & Software
    40. gavel Legal
    41. sports_soccer Leisure & Sports
    42. inventory_2 Logistics & Warehousing
    43. supervisor_account Management
    44. supervisor_account Management Consultancy
    45. supervisor_account Manufacturing & Production
    46. campaign Marketing
    47. build Mechanical Engineering
    48. perm_media Media & PR
    49. local_hospital Medical
    50. local_hospital Military & Public Safety
    51. local_hospital Mining
    52. medical_services Nursing
    53. local_gas_station Oil & Gas
    54. biotech Pharmaceutical
    55. checklist_rtl Project Management
    56. shopping_bag Purchasing
    57. home_work Real Estate
    58. person_search Recruitment Consultancy
    59. store Retail
    60. point_of_sale Sales
    61. science Scientific Research & Development
    62. wifi Telecoms
    63. psychology Therapy
    64. pets Veterinary
    View All Regulatory Compliance Jobs