If you are an experienced Regulatory Affairs professional aiming to work on global submissions, lifecycle management, and regulatory strategy, this opportunity at Novo Nordisk could be your next big career move.
Based in Bangalore, this role within the Global Regulatory Affairs – Diabetes team focuses on enabling global patient access through high-quality regulatory submissions and cross-functional collaboration.
With increasing demand for Regulatory Affairs jobs in India, especially in global pharma organizations, this position offers exposure to MAA, NDA, BLA submissions, CTD dossiers, labeling, and pharmacovigilance documentation—making it highly valuable for career growth.
📌 Job Overview
- Role: Regulatory Professional – Regulatory Affairs
- Company: Novo Nordisk
- Location: Bangalore, Karnataka
- Experience: 6–8 Years
- Qualification: M.Sc or relevant life sciences degree
- Department: Global Regulatory Affairs (RA Diabetes)
- Deadline: 15 April 2026
🧩 Key Responsibilities
As a Regulatory Affairs professional, you will:
- Support global regulatory submissions (MAA, NDA, BLA, CTA, IND)
- Prepare and publish CTD/eCTD dossiers
- Coordinate health authority interactions (FDA, EMA, PMDA)
- Maintain marketing authorizations and lifecycle activities
- Develop and maintain core labeling (CCDS, regional labels)
- Contribute to pharmacovigilance documents:
- PSUR
- DSUR
- Risk Management Plans (RMP)
- Manage regulatory data in RIM systems
- Support regulatory meetings (briefing books, minutes, rehearsals)
- Drive process improvements and submission efficiency
- Collaborate with cross-functional teams (Clinical, Safety, Medical Affairs)
🎓 Qualifications & Skills
To succeed in this Regulatory Affairs job:
- Master’s degree in Life Sciences / Regulatory / Pharmacy
- 6–8 years experience in Regulatory Affairs or related domain
- Strong knowledge of:
- CTD format & global submissions
- Regulatory procedures (US, EU, global markets)
- Hands-on experience with:
- RIM systems
- Submission publishing tools
- Expertise in:
- Labeling strategies
- Lifecycle management
- Pharmacovigilance documentation
- Strong stakeholder management & communication skills
- Ability to work across global cross-functional teams
🌍 Why Join Novo Nordisk?
Working at Novo Nordisk means:
- Exposure to global regulatory strategy and submissions
- Work on innovative therapies in chronic diseases (Diabetes focus)
- Strong learning ecosystem and career growth opportunities
- Collaborative environment with global stakeholders
- Competitive benefits aligned with career stage
💰 Salary Insight (Estimated)
- Expected Salary Range: ₹12 LPA – ₹22 LPA
(Based on 6–8 years Regulatory Affairs experience in Bangalore pharma/CRO market)
📩 How to Apply
