Nandini Nimbalkar
Associate - MRC | Global Drug Regulatory Affairs | CMC | Sandoz pharmaceuticals Ltd |Ex-Glenmark
- Role
- Regulatory Affairs Associate at Sandoz
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Nandini Nimbalkar
A regulatory affairs professional with extensive experience in the preparation and submission of regulatory life cycle maintenance documents, including variations, renewals, and second wave submissions across regulated markets. Skilled in evaluating proposed changes, providing timely regulatory input, and ensuring accelerated product approvals. My expertise encompasses the development and implementation of regulatory strategies that support product development and global registration, while ensuring compliance in manufacturing and quality programs throughout the product life cycle. With a strong track record in preparing dossiers for a variety of drug products, including oral solid dosage forms and injectables, I have successfully adapted submissions to meet CTD, ACTD and country-specific formats. I am open to opportunities that align with my expertise in regulatory affairs and innovation in drug product registration. Let\'s connect to explore potential collaborations.
Experience
Regulatory Affairs Associate
Mar 2024 — Present · Hyderabad, IN
Education
Bombay College of Pharmacy Kalina Santacruz (E) Mumbai - 400 098
M.pharm
2019 — 2021
Gurunanak college of pharmacay ,nagpur
B.pharm
2015 — 2019
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