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974 Regulatory Affairs Consultant jobs in India

Lead Consultant - Regulatory Affairs

Mumbai, Maharashtra Genpact

Posted today

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Job Description

Ready to build the future with AI?
At Genpact, we don’t just keep up with technology—we set the pace. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Management Trainee/ Assistant Manager- Lead Associate or Lead Consultant, Regulatory affairs.
Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Responsibilities:
• The core responsibility will be to review the authored documents, compare them with source documents, ensure there are no transcription or formatting errors, no quality errors, and ensure compliance with regulatory guidelines.
• Maintaining the quality of documents through quality reviews ensuring “No Queries” received from Health Authorities
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Able to prioritize & execute the project according to the project plan/timelines/schedules.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
• Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Effective leadership, communication, and interpersonal skills.
• Advanced knowledge of MS Office.
• Superior attentiveness to detail & has a strong regulatory background.

Qualifications we seek in you!
Bachelor’s or master’s degree required in science, engineering or related field (advanced degree preferred).
Why join Genpact?
• Lead AI-first transformation – Build and scale AI solutions that redefine industries
• Make an impact – Drive change for global enterprises and solve business challenges that matter
• Accelerate your career—Gain hands-on experience, world-class training, mentorship, and AI certifications to advance your skills
• Grow with the best – Learn from top engineers, data scientists, and AI experts in a dynamic, fast-moving workplace
• Committed to ethical AI – Work in an environment where governance, transparency, and security are at the core of everything we build
• Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.
Let’s build tomorrow together.

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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

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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.

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RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

Chennai, Tamil Nadu 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.

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

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RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

Hyderabad, Andhra Pradesh EY