Jayesh Suryawanshi
Aurobindo Pharma || NIPER-G || GPAT AIR 102 || GAT-B AIR 126 || IIT BHU AIR 25 || GATE--XL || NIPER JEE || CUET-PG ||
- Role
- Research Associate-ii (Regulatory Affairs) at Aurobindo Pharma Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Jayesh Suryawanshi
I hold a Master’s degree in Pharmacy (Pharmaceutical Technology – Formulations) from NIPER Guwahati and a Bachelor’s degree in Pharmacy from R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur.In 2023, I secured an All India Rank of 102 in GPAT and successfully cleared GATE XL, NIPER JEE, GAT-B, CUET PG, IIT BHU M.Pharm, and ICT M.Tech entrance exams — demonstrating my commitment to academic excellence and continuous learning.I completed my 11 months of internship at Encube Ethicals Pvt. Ltd. in the Formulation Development Department, where I gained hands-on experience in semi-solid formulation development, process optimization, and topical product characterization.Currently, I am working in the Regulatory Affairs Department (CMC – Pre and Post Approval Submissions) with a focus on the U.S. market, where I contribute to regulatory documentation, dossier compilation to ensure compliance with USFDA guidelines.I am passionate about bridging formulation development with regulatory strategy to support the smooth approval and commercialization of high-quality pharmaceutical products in the global market.
Experience
Research Associate-ii (Regulatory Affairs)
Jul 2025 — Present · Hyderabad, IN
ANDA CMC professional focused on US generics, with experience in topical formulations(Cream, Gel, Solution, Ointment, Shampoo) and regulatory documentation(Gel, Cream) 1. Expertise in technical CMC documents review (F&D, ADL, QA,QC, DMF, Vendor Docs API, RM, PM), as well as coordinating cross-functional teams for dossier data requirements.2. Preparation of Annual Report3. Expertise is Pre- ANDA document review.4. Familiar & Proficient in handling: orange book, drug@fda, IIG Database, DailyMed, Impurities calculations, REMS, product specific guidances, CTD modules, FDA guidances and regional requirements.
Education
R. C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR
Bachelor of Pharmacy - BPharm, Bachlor of pharmacy
2019 — 2023
NIPER Guwahati
M pharm in Pharmaceutical Technology (Formulations), Pharmaceutical Technology (Formulations)
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