756 Compliance Standards jobs in India

Manager - Regulatory & Technical Standards Compliance

Bengaluru, Karnataka ₹2000000 - ₹2500000 Y Standard Chartered Bank

Posted 1 day ago

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Job Description

Job ID: 36710

Location: Bangalore, IN

Area of interest: Technology

Job type: Regular Employee

Work style: Office Working

Opening date: 11 Aug 2025

Job Summary

  • The role will work closely with Country CISOs / ISRO / CISRO / ICS / TTO representatives within the bank to ensure the Banks ICS regulatory obligations are met on time.

  • The Group Chief Information Security Officer (CISO) organisation is instrumental in protecting and ensuring the resilience of Standard Chartered Bank's data and IT systems by managing information and cyber security (ICS) risk across the enterprise. As a critical function reporting into the Group Chief Technology, Operations and Transformation Officer, the Group CISO serves as the first line of defence for assuring ICS controls are implemented effectively and in accordance with the ICS Risk Framework, Policy and Standard, and for instilling a culture of cyber security within the Bank.

  • This includes supporting the ICS Legal Regulatory Mandatory compliance assessments for all markets.

Key Responsibilities

Business

  • The role will work closely with Country CISOs / ISRO / CISRO / ICS / TTO representatives within the bank to ensure the Banks ICS regulatory obligations are met on time.

Processes

The role will:

  • The role is responsible to complete regulatory compliance assessments and support all SCB regions in meeting critical and complex ICS regulatory obligations.
  • The role oversees all ICS regulatory compliance assessment activities (design and operating effectiveness), supports issue remediations and ensures these are performed to quality and submitted to regulators on time.
  • The role requires technical ICS domain knowledge, SME skills in regulatory compliance assessments / audit / risk & control, and strong senior stakeholder management abilities (RCISO, CISO, ISRO, ICS/Technology/CIO Domains).
  • Regularly identify and implement opportunities for efficiencies across processes, systems, and infrastructure.

People & Talent Management

  • Working in close collaboration with CISO, risk and control partners across all functions to effectively embed a strong culture of risk awareness and good conduct,
  • Track and sustain a continuous improvement and innovation culture,
  • Support a culture of diversity and inclusion to bring the best out of our people,

Risk Management

  • Work closely with AIC LRM cluster leads to drive an effective risk management culture and compliance mindset,
  • Mature the Bank's ability to proactively identify and manage cyber threats through quality compliance assessments at a Design and Operating level

Governance

  • Track and follow up for timely and accurate completion of ICS regulatory compliance assessments and ensure all governance metrics are met
  • Support appropriate oversight and follow-up for resolution of high impact risk and issues

Regulatory & Business Conduct

  • Display exemplary conduct and live by the Group's Values and Code of Conduct. Including tracking and remediation of conduct issues
  • Effectively and collaboratively support to identify, escalate, mitigate, and resolve risk, conduct and compliance matters.

Key Stakeholders

  • Head, App & Infra Compliance
  • AVP / VP, LRM App & Infra Compliance
  • Regional and Country - Chief Information Security Officers (CISOs) and delegate
  • Information Security Risk Officers and delegate
  • ICS Service domains
  • COOs/CIOs of different businesses/functions
  • Group Internal Audit

Other Responsibilities

  • Embed Here for good and Group's brand and values in ICS R&G; Perform other responsibilities assigned under Group, Country, Business or Functional policies and procedures; Multiple functions (double hats);

Skills and Experience

  • Business Process Design
  • Process Management
  • Risk Management
  • Regulatory Environment – Financial Services
  • Program Management

Qualifications

  • Minimum 10 years of experience in Cyber Security, technology and ICS risk management, A proven track record of leading successful teams is priority.
  • Excellent interpersonal skills to foster positive relationships with internal and external stakeholders.
  • Thorough understanding of ICS business processes, risks, threats, internal controls, and experience with regulators and multi-stakeholder organisations.
  • Ability to collect and analyse data and make recommendations in written and oral form.
  • Strong ability to liaise with all parts of the Bank, including senior security, risk and business stakeholders.
  • Highly effective oral and written communication skills, with an ability to influence and to gain the respect of senior stakeholders and peers. Fluency in English.
  • Bachelor's Degree in Information Technology, Cybersecurity, Business Management, or other related discipline. Professional certifications have an advantage (e.g., CISA, CISSP, CISM etc).

About Standard Chartered

We're an international bank, nimble enough to act, big enough for impact. For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us.

Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion.

Together we:

  • Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
  • Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
  • Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term

What we offer

In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.

  • Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations.
  • Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum.
  • Flexible working options based around home and office locations, with flexible working patterns.
  • Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
  • A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning.
  • Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.
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Regulatory Compliance

Mumbai, Maharashtra Abbott

Posted 11 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
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Regulatory Compliance

Noida, Uttar Pradesh ₹1500000 - ₹2500000 Y Paytm

Posted 1 day ago

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Job Description

About the Team:

The Compliance department has five areas of responsibilityidentification, prevention, monitoring, resolution, and advisory for the entity with respect to regulations/ laws.

About the role:

This role includes managing regulatory compliance for our Digital Lending Business. The role entails advising the Digital Lending business units of the relevant regulatory expectations and ensuring timely monitoring and detection of compliance-related issues. The successful candidate will be responsible for individually contributing and ensuring compliance with relevant laws, regulations, and guidelines related primarily to Digital Lending. The ideal candidate should have experience in relevant domain dealing with RBI obligations preferably in a fintech environment, bank and possess strong self-driven skills to manage compliance effectively.

Expectations/ Requirements:

1) Regulatory Compliance Management: Monitoring and interpreting regulations and guidelines in the domain of Digital Lending and ensuring compliance with applicable laws, regulations, and guidelines. Provide informed compliance advisory to the internal stakeholders on the applicability of regulatory laws and guidelines.

Knowledge of regulatory requirements of RBI & NPCI relating to UPI, Bill Payments and Merchant Acquiring/ Payment Aggregation segments will be an added advantage.

2) Policy and Procedure Development: Develop, implement, and maintain compliance policies and procedures ensuring that they are up-to-date.

3) Compliance Monitoring: Establish and implement a robust compliance monitoring program to assess the effectiveness of internal controls, processes, and procedures related to digital lending products. Manage audits and ensure timely, accurate responses to regulatory/ third-party inquiries and inspections.

4) Regulatory Reporting: Prepare and submit timely and accurate compliance reports to senior management and regulators, as required.

5) Risk Assessment: Conduct regular risk assessments related to digital lending products, identify potential compliance risks, and implement appropriate risk mitigation measures.

6) Training and Awareness: Develop and deliver training programs to employees and relevant stakeholders to enhance compliance awareness.

7) Relationship Management: Collaborate with cross-functional teams such as legal, risk, operations, and technology to ensure compliance and resolve any compliance-related issues.

8) Stay Updated: Stay updated with changes in relevant laws, regulations, and guidelines and proactively implement necessary changes in compliance policies and procedures.

Superpowers/ Skills that will help you succeed in this role:

1)Work Experience: 7+ Years of relevant experience in regulatory compliance, preferably in a fintech environment or bank.

2)Strong Knowledge: Sound understanding of RBI and NPCI regulations and applicable laws. Understanding of management of compliance function.

3)Analytical Skills: Ability to conduct risk assessments, analyze complex information, and provide practical and effective compliance solutions.

4)Attention to Detail: Strong attention to detail and accuracy in compliance monitoring, reporting, and documentation.

5)Proactive and Collaborative Approach: Proactive approach to identifying and addressing potential compliance risks and issues in a timely manner. Interpersonal skills and ability to collaborate and work effectively with cross-functional teams, senior management, and regulators.

6)Adaptability: Ability to work independently and as part of a team, ability to adapt to changing regulatory requirements and business needs and implement necessary changes in compliance policies and procedures.

7)Ethical Conduct: High level of integrity, professionalism, and ethical conduct in dealing with sensitive and confidential information.

8)Proficient in using compliance management software and tools.

Education:

Bachelors degree in Finance, Law, Business Administration, or related field. A Masters degree or professional certification (e.g., CA, CS, CFA, FRM) is preferred.

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Regulatory Compliance

Mumbai, Maharashtra Abbott

Posted today

Job Viewed

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

    Lead Regulatory Compliance Officer (Remote)

    248001 Dehradun, Uttarakhand ₹1100000 Annually WhatJobs

    Posted today

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    Job Description

    full-time
    Our client is seeking an experienced and diligent Lead Regulatory Compliance Officer to ensure adherence to all applicable laws, regulations, and industry standards. This critical role operates entirely remotely, providing an opportunity for a compliance expert to influence policy and practice from anywhere. You will be responsible for developing, implementing, and maintaining a comprehensive compliance program. This includes conducting internal audits, risk assessments, and providing guidance to business units on regulatory requirements. The ideal candidate possesses a strong understanding of financial regulations, anti-money laundering (AML), know-your-customer (KYC) principles, and data privacy laws. You will play a key role in fostering a culture of compliance throughout the organization, mitigating risks, and safeguarding the company's reputation. This position requires exceptional analytical skills, attention to detail, and the ability to communicate complex regulatory information clearly and effectively to diverse audiences.

    Responsibilities:
    • Develop, implement, and manage the company's regulatory compliance program.
    • Conduct regular risk assessments to identify potential areas of compliance vulnerability and risk.
    • Develop and implement corrective action plans for identified compliance issues.
    • Ensure compliance with all relevant financial regulations, including but not limited to AML, KYC, sanctions screening, and data privacy laws (e.g., GDPR, CCPA).
    • Create and deliver compliance training programs for employees at all levels.
    • Monitor changes in regulations and industry best practices and update policies and procedures accordingly.
    • Serve as the primary point of contact for regulatory inquiries and examinations.
    • Conduct internal audits and reviews to assess compliance effectiveness.
    • Investigate potential compliance breaches and recommend appropriate actions.
    • Advise management and business units on regulatory requirements and implications.
    • Maintain accurate and up-to-date compliance documentation and records.
    • Foster a strong culture of compliance and ethical conduct throughout the organization.
    • Collaborate with legal, risk management, and other departments to ensure a cohesive approach to compliance.
    Qualifications:
    • Bachelor's degree in Law, Finance, Business Administration, or a related field. A Master's degree or professional certification (e.g., CCEP, CRCM, CAMS) is highly preferred.
    • Minimum of 7-10 years of experience in regulatory compliance, preferably within the financial services or technology sector.
    • In-depth knowledge of financial regulations, AML/KYC requirements, and data privacy laws.
    • Proven experience in developing and implementing compliance programs and policies.
    • Strong analytical, problem-solving, and risk assessment skills.
    • Excellent written and verbal communication skills, with the ability to explain complex regulatory requirements clearly.
    • Demonstrated ability to work independently and manage multiple priorities in a remote setting.
    • High ethical standards and a commitment to integrity.
    • Experience in conducting internal audits and investigations.
    • Proficiency in compliance management software is a plus.
    This remote role offers a significant impact on maintaining the integrity and trustworthiness of our client's operations.
    This advertiser has chosen not to accept applicants from your region.

    RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

    Hyderabad, Andhra Pradesh ₹600000 - ₹1800000 Y EY

    Posted 1 day ago

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    Job Description

    At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.

    EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior

    As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

    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

    • B.E/B.Tech (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 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

    EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.

    Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate.

    Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

    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

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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 

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    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.

    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.

    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.
     

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