Sun Pharmaceutical Industries Ltd. is the 4th largest specialty generic pharmaceutical company globally, with a strong presence in the US, Europe, and emerging markets. Known for its innovation and compliance, Sun Pharma offers excellent career growth in Regulatory Affairs, R&D, and Manufacturing.
Sun Pharma, a global leader in pharmaceuticals, is hiring M.Pharm graduates with 6–10 years of experience in Regulatory Affairs (US Market) for its Baroda location.
Key Responsibilities:
- Prepare and review CMC (Chemistry, Manufacturing, Controls) regulatory submissions for the US market.
- Handle post-approval submissions, variations, and amendments.
- Ensure compliance with USFDA, ICH, and other regulatory guidelines.
- Collaborate with cross-functional teams for timely submissions.
- Review technical documents, protocols, and reports for accuracy.
Skills Required:
- Strong knowledge of US regulatory guidelines (e.g., ANDA, NDA, DMF).
- Experience in eCTD submissions and lifecycle management.
- Expertise in CMC regulatory affairs and post-approval changes.
- Excellent communication and analytical skills.
About Sun Pharma
Sun Pharmaceutical Industries Ltd. is the 4th largest specialty generic pharmaceutical company globally, with a strong presence in the US, Europe, and emerging markets. Known for its innovation and compliance, Sun Pharma offers excellent career growth in Regulatory Affairs, R&D, and Manufacturing.
How to Apply?
Interested candidates can share their updated resumes to:
📩 rosemary.varghese@sunpharma.com
📍 Job Location: Baroda, Gujarat
