M-Regulatory Affairs
GenpactMumbai, Maharashtra, India
Posted April 9, 2026
Full Time
About the Company
Genpact is a global professional services firm that delivers advanced technology and process-intelligence solutions across banking, insurance, healthcare, energy, and other industry verticals. Leveraging artificial intelligence and data-driven insights, the company transforms operations to deliver measurable business outcomes for leading enterprises worldwide. Its long-standing client relationships and strong partner ecosystem enable innovative, scalable solutions that accelerate digital transformation. Genpact's culture of continuous learning and client-centric focus drives lasting value and positions it as a trusted partner for organizations seeking to modernize and optimize their processes.
Job Description
Genpact is seeking a Manager - Regulatory Affairs to lead and execute CMC regulatory strategies for assigned post-approval pharmaceutical products. The role requires a Master's degree in Pharmacy, Science, or related field with at least 7 years of global Regulatory CMC experience.
Requirements
- Leading and executing CMC regulatory strategies
- Authoring, reviewing, and coordinating CMC documentation
- Collaborating with cross-functional teams
- Ensuring timely approvals and product supply continuity
- Delivering regulatory milestones
- Strong experience in CMC requirements for small molecule/biologic products
- Critically reviewing detailed scientific information
- Demonstrating strong written and verbal communication skills
- Identifying regulatory risks and opportunities
- Participating in departmental and cross-functional continuous improvement initiatives
- Demonstrating flexibility and resilience in managing changing priorities
- Exhibiting strong leadership, stakeholder management, and interpersonal skills
Benefits
- Health Insurance
- Retirement Plan
- Generous Paid Time Off
- Tuition Reimbursement
- Life Insurance
