Swati Chavan
Regulatory Affairs Specialist | Global Submissions (EMA,USFDA, SAHPRA) | Biologics| Biosimilars| Cell line gene therapy (CGT)| Compliance Expert
- Role
- Regulatory Affairs Specialist at Adcock Ingram
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Swati Chavan
Regulatory Affairs Specialist with hands-on experience in global submissions across…
Experience
Regulatory Affairs Specialist
Nov 2024 — Present · Bengaluru, IN
Lead preparation and review of CMC sections for biologics and biosimilars. Manage regulatory strategies, lifecycle submissions, and post-approval change management.🤝 Collaborate with R&D, QA, and Manufacturing teams to ensure compliance and timely submissions. Support global submission planning and respond to regulatory queries effectively. Utilized tools like Lorenz eValidator and DocuBridge for compliant submissions.
Education
P.S.G.V.P Mandal College of Pharmacy, Shahada – North Maharashtra University | 2018 | Jalgaon
🎓 B.Pharmacy in Pharmaceutical Sciences, Pharmaceutical Sciences
R. C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR
M.Pharm, Natural Products Chemistry and Pharmacognosy with pharmacology
2018 — 2020
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