Regulatory Affairs Jobs at Genpact | Chemistry Candidates Apply Now
Regulatory Affairs Jobs at Genpact. They have announced an exciting opportunity for a Manager – Regulatory Affairs (CMC Documentation) in Mumbai. This role is ideal for regulatory professionals with strong expertise in Chemistry, Manufacturing, and Controls (CMC), lifecycle management, and global regulatory compliance who want to contribute to AI-driven transformation and large-scale enterprise solutions.
Job Description – Manager Regulatory Affairs (LIF022874)
Inviting applications for the role of Manager, Regulatory Affairs-CMC Documentation,
This role directly contributes to the Company’s revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Senior Manager is required to:
Responsibilities
- Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation.
- Coordinate with manufacturing and quality teams to ensure accurate and timely data for regulatory submissions.
- Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports.
- Experienced in authoring assessment reports and Part2/ Expert reports for Dossiers.
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Qualifications we seek in you!
Preferred Qualifications/ Skills
- Manage execution / authoring of CMC documentation (Module 1, 2 and 3) for life cycle management – post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Knowledge of regulatory guidelines and relevant applications.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Why join Genpact?
- Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation.
- Make an impact – Drive change for global enterprises and solve business challenges that matter.
- Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities.
- Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day.
- 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 tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
- Let’s build tomorrow together.
Job Details
- Job Title: Manager Regulatory
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Job Posting: Dec 24, 2025, 3:03:27 PM
- Unposting Date: Jan 23, 2026, 11:59:00 PM
- Master Skills List: Operations
- Job Category: Full Time.
