111 Regulatory Affairs Manager jobs in Mumbai

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities:

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities:

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities

About USV Private Limited:

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function: Biologics

Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities:

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.

4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities

Purpose:

The position is for working on product registrations in Mexico and LATAM including compiling dossiers, answering queries from regulatory agencies, liaising with the cross-functional teams to obtain needful documents for product registration and co-ordinate on the requirements from the regional partners and regulatory agents. Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders.

Job Responsibilities:

• Preparing and submitting regulatory dossiers in Mexico and LATAM countries.
• Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders.
• Liaising with the cross-functional teams for documents for registration and reviewing them.
• Liaising with regulatory agents in Mexico and LATAM countries and addressing their requirements for regulatory filings.
• Addressing any queries or deficiencies from the regulatory agencies or partners or regulatory agents and ensuring product registration in the shortest time.
• Addressing any post approval requirements and filings.
• Ensuring the dossiers are submitted and registered as per the schedule.

Qualifications & Pre-Requisites:

• Regulatory experience in Mexico and LATAM markets at managerial position.
• Should be an M.Pharm/M.Sc
• Good communication and planning skills.

Additional notes

• Will need to work in different shifts.

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Inviting applications for the role of Manager or Senior Manager, 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:
• Leading project teams, providing technical guidance, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
• 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. 
• Ability to lead client meetings and managing project governance.
• Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
• Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables, training team as well as client on a need-basis and providing solutions in real time.
• Improvise the process and outcomes by implementing continuous improvement initiatives leveraging six-sigma methodologies, RPA/AI opportunities for harmonization, simplification, and automation
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Ability to prioritize & execute the project according to the project plan/ timelines/ schedules. 
• Ensure established policies and procedures of the organization/client are followed and ensure compliance. 
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate project status & report to stakeholders using different communication channels.
• Contribute to draft Request for information and/ or Request for proposals for new client/ business opportunities. Provide inputs to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Superior attentiveness to detail & has a strong regulatory background.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Demonstrated effective leadership, communication, and interpersonal skills.
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Key Accountabilities :

Propose efficient regulatory pathway for New Product Introduction
 Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
ollaborate with other functions such as R&D, Quality, Supply chain, Project
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
esponsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
ell versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
ddress queries from CDSCO/SFDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
anage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
esponsible for Subject expert committee (SEC) meetings including preparation of slide
deck in co-ordination with cross functional teams and SEC deliberation

Track all SEC meetings to identify and recommend new product ideas/opportunities
aligned with current business needs
rovide Regulatory Support for timely new product launches

Minimum Education:
M. Pharm/B. Pharm
Minimum Experience Required:
8-10 years