Job Title: Senior Manager – Regulatory Affairs
Company: Genpact
Location: Hyderabad, India
Industry: Pharma / Healthcare / Clinical Research
Functional Area: Drug Regulatory Affairs (DRA)
Qualification: Master’s in Life Sciences
Experience: Relevant experience in regulatory affairs & labeling
Application Deadline: 20th July 2025
About Genpact
Genpact is a leading global professional services firm, delivering transformative outcomes for Fortune 500 companies. With over 125,000+ employees across 30+ countries, Genpact leverages deep industry expertise, digital operations, and AI-driven solutions to help businesses thrive. Their mission is to create a world that works better for people, making them a preferred employer in the pharmaceutical and healthcare sectors.
Job Description: Senior Manager – Regulatory Affairs
Genpact is seeking an experienced Regulatory Affairs Senior Manager to oversee labeling processes, ensure compliance, and drive continuous improvements in regulatory submissions.
Key Responsibilities:
- Monitor and optimize regulatory processes for efficiency.
- Lead a team to ensure timely and high-quality submissions.
- Resolve regulatory issues promptly and ensure compliance with US & EU labeling norms.
- Collaborate with global teams on labeling projects and corporate label implementation.
- Track performance metrics and implement cost-saving measures.
- Prepare Company Responses (MAH) for health authority queries.
- Ensure local affiliates adhere to corporate labeling standards.
Candidate Profile:
- Master’s degree in Life Sciences (Pharmacy, Biotechnology, or related field).
- Strong expertise in CCDS, US & EU labeling regulations.
- Proven ability to manage cross-functional teams and guide decision-making.
- Excellent communication skills for senior management interactions.
- Knowledge of regulatory SOPs and industry best practices.
Why Join Genpact?
- Work with a global leader in pharma regulatory affairs.
- Career growth in a dynamic, AI-driven environment.
- Competitive salary and benefits.
- Opportunity to impact patient safety & compliance through effective labeling strategies.
How to Apply?
Interested candidates can apply before 20th July 2025. For more details,