Global professional services company Genpact is inviting applications for the position of Regulatory Affairs Specialist / Assistant Manager โ Regulatory Affairs (CMC & Labelling) in Mumbai.
This opportunity is ideal for professionals with expertise in Regulatory Affairs, CMC documentation, CTD submissions, and pharmaceutical compliance. The role focuses on regulatory support for consumer healthcare products and dossier preparation aligned with international regulatory standards.
Genpact, known for combining AI-driven digital solutions with domain expertise, is expanding its regulatory services team to support global pharmaceutical and healthcare clients.
Key Responsibilities
The Regulatory Affairs Specialist will handle multiple regulatory submission and compliance activities, including:
- Managing client-based requirements for new product registrations
- Supporting pre-approval and post-approval regulatory submissions
- Preparing and compiling technical documentation for consumer healthcare products
- Authoring Quality Overall Summaries (QOS) and Module 3 CTD sections
- Writing CMC quality documents for regulatory dossiers
- Reviewing manufacturing, analytical, validation, and stability documentation
- Assessing existing quality documentation during project renewals
- Ensuring regulatory submissions meet global regulatory guidelines and timelines
Required Qualifications
Candidates applying for this Genpact Regulatory Affairs job should have:
- B.Pharm / M.Pharm / B.Sc / M.Sc in Life Sciences or related discipline
- Experience in Regulatory Affairs, CMC documentation, or dossier preparation
- Knowledge of CTD modules and regulatory submission formats
- Understanding of manufacturing, validation, and stability data evaluation
- Strong documentation and regulatory compliance skills
Preferred Skills
- Regulatory submissions for consumer healthcare or pharmaceutical products
- CMC regulatory documentation
- Module 3 dossier writing
- Knowledge of global regulatory guidelines
Salary (Estimated)
- โน8,00,000 โ โน18,00,000 per year (based on industry benchmarks for Regulatory Affairs roles)
Why Join Genpact?
Working at Genpact offers strong career growth in the pharmaceutical regulatory domain.
Benefits include:
- Exposure to global regulatory affairs projects
- Opportunities to work with AI-enabled regulatory solutions
- Career advancement through mentorship and learning programs
- Collaboration with international pharmaceutical clients
- A workplace culture focused on innovation, integrity, and inclusion
Job Details
| Field | Information |
|---|---|
| Position | Regulatory Affairs Specialist |
| Department | Regulatory Affairs / CMC |
| Company | Genpact |
| Location | Mumbai, Maharashtra, India |
| Employment Type | Full-time |
| Mode | On-site |