Sr Executive-Regulatory Affairs
IndiaFull-time3–4 yrsPosted 3 weeks ago
Mid-level pharma role at RPG Group (CEAT, KEC, RPG companies). Needs 3–4 years and an M.Sc, B.Pharm or M.Pharm.
About the role
Sr Executive-Regulatory Affairs at RPG Group (CEAT, KEC, RPG companies). Regulatory Activities.
What you'll do
- Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures
- Filing amendments, updates with relevant health agencies
- Preparation of response to queries received from health authorities and customers
- Evaluation of regulatory impact and review of QMS documentation
- Coordination with various stake holders at site for documentation
What you need
- Regulatory affairs
- Documentation
- ISO 9001