Remya Panicker
Regulatory Affairs- Global markets
- Role
- Regulatory Affairs Assistant Manager at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Remya Panicker
Regulatory Affairs professional - Pre approval submission- Post approval (safety variations and CMC variations)- Renewals, sunset clause filings - CR evaluation and gap analysis - Responses to agency queries- Good grabs on tools such as eCDT software, lorenz e validator, trackwise, SAP and documentum
Experience
Regulatory Affairs Assistant Manager
Aug 2024 — Present · Mumbai, IN
Compilation of Variation packages for Global market in accordance with country specific guidelines.Responds to agencies queries.Coordinate with cross functional teams.Evaluation of change request forms.
Education
Ramniranjan Jhunjhunwala College (Autonomous)
Master of Science - MS, Analytical Chemistry
Institute of pharmaceutical management Dombivli
Postgraduate diploma, Regulatory Affairs
SIES College of Arts, Science & Commerce SION(W)
Bachelor of Science - BS, Chemistry
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