Specialist, Regulatory Affairs
Genpact
Mumbai, Maharashtra, India3h agovia LinkedIn
This job at a glance
- Who can apply
- Freshers
- Must know
- MarketingStakeholder managementPower BISAPMicrosoft Office
- Work
- On-site in Mumbai
- Pay
- Not stated by the employer.
- Skill demand
- Stakeholder management35%Marketing21%Power BI8%SAP7%of 99 similar fresher jobs posted in India this week
- Listed
- 10 Nov 2026 · still open
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About the Role
This section is not present in the provided text.
Key Responsibilities
- Implement CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies.
- Prepare and review information required for the development of regulatory CMC dossiers for commercial products of small molecules/pharma, large molecules/biologicals, etc.
- Author CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions under the direction of team scientists.
- Review scientific information to assess technical merits and suitability of scientific rationale, ensuring clear presentation and data-supported conclusions.
- Prioritize and execute projects according to project plans, timelines, and schedules.
- Work with cross-functional teams to track and follow up on outstanding documentation.
- Coordinate project status and reporting to stakeholders using different communication channels.
- Understand job responsibilities and processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality Control, etc.
- Participate in departmental improvement activities such as system modifications, maintenance of standard operating procedures, and internal guidelines.
- Demonstrate flexibility in responding to changing priorities, multi-tasking, and dealing with unexpected events.
Requirements & Tech Stack
- Prior experience in manufacturing sites, Quality Assurance, Quality Control is preferable.
- Experience in RA/QA/QC systems and tools such as SAP, Documentum, Veeva, LIMS, Spotfire, Power BI is preferable.
- 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 to key stakeholders.
- Advanced knowledge of MS Office.
- Superior attentiveness to detail.
- Effective leadership, communication, and interpersonal skills.
Qualifications
This section is not present in the provided text.