Looking to build a career in Regulatory Affairs in the pharmaceutical industry? Lupin is hiring a Trainee Executive – Regulatory Affairs at its Pune biotech facility. This opportunity is ideal for candidates with 3–5 years of regulatory experience in pharma, biotech, or biosimilars.
This role offers hands-on exposure to global regulatory submissions, GMP documentation, and post-approval changes (PAC) across domestic, emerging, and regulated markets.
Advertisement
Job Overview
- Role: Trainee Executive – Regulatory Affairs
- Location: Pune, Maharashtra
- Company: Lupin
- Experience: 3–5 Years
- Qualification: M.Sc / M.Pharm / Pharma Tech
Key Responsibilities
- Draft and compile regulatory submission dossiers for domestic and international markets
- Handle queries from global health authorities and ensure timely responses
- Review and ensure compliance of GMP documents as per regulatory standards
- Prepare and manage Post Approval Change (PAC) applications
- Coordinate with cross-functional teams for Marketing Authorization Applications (MAA)
- Work on regulatory submissions via online portals (India & global markets)
- Support regulatory strategy for biosimilar products (preferred)
Eligibility Criteria
Education:
- Master’s in Biotechnology / Biopharmaceutics
- OR Postgraduate in Pharmacy / Pharmaceutical Technology
Experience:
- 3–5 years in Regulatory Affairs (Pharma/Biotech)
Skills Required:
- Strong understanding of regulatory requirements (India, US, EU, emerging markets)
- Experience with eCTD submissions and regulatory documentation
- Knowledge of biosimilars (preferred but not mandatory)
- Excellent written and verbal communication skills
Why Join Lupin?
- Work with a leading global pharmaceutical company
- Exposure to regulated markets (USFDA, EMA, etc.)
- Career growth in Regulatory Affairs and global compliance
- Opportunity to work on biosimilars and advanced therapies
- Collaborative and learning-driven work environment
How to Apply
