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96 Policy Implementation jobs in India

Regulatory Compliance

Mumbai, Maharashtra Abbott

Posted 16 days ago

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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

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.

RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager

Chennai, Tamil Nadu EY

Posted today

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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 - Senior

Hyderabad, Andhra Pradesh EY

Posted today

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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.

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

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

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