Sonali Pawar
Regulatory Affairs Trainee | Pharmaceuticals | Expertise in US & European Market Regulations | Documentation & Compilation
- Role
- Regulatory Affairs Consultant at Nuvo Consultancy
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sonali Pawar
Regulatory Affairs Officer with 3+ year of experience supporting EU and US regulatory…
Experience
Regulatory Affairs Consultant
Dec 2022 — Present · Mumbai, IN
Prepared, reviewed, and compiled Abbreviated New Drug Applications (ANDAs)(oral solid dosage) for the United States market and Marketing Authorization Applications (MAAs)(oral solid dosage and topical solution) for the European market through national procedure and decentralized procedure• Conducted a gap assessment report for oral solid dosage forms and injectable dossiers• Prepared Drug Master File (DMF) for the Active Pharmaceutical Ingredient (API) for the United State market and submit their annual reports• Prepared Active Substance Master File (ASMFs) for the Active Pharmaceutical Ingredient (API) for the European market.• Filed an Amendment for Active Pharmaceutical Ingredient (API) for the European market• Ensured compliance with global regulatory requirements, including United State Food and Drug Administration (USFDA), European Medicines Agency (EMA) and other relevant authorities• Responded to regulatory authority queries efficiently
Education
IPM institute of pharmaceutical management
Post graduation diploma
2022 — 2023
Dr. L.H. Hiranandani College of Pharmacy
Bachelor of Pharmacy - BPharm
2018 — 2022
Dr. L.H.Hiranandani College of Pharmacy University of Mumbai
B Pharmacy
2018 — 2022
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