Nilesh Binnar

B. pharm graduate currently pursuing M. pharm in Regulatory Affairs with hands-on experience in pharmaceutical retail operations. Experienced with CTD/eCTD, ICH guidelines, (ANDA, NDA, IND, DMF), medical device regulations, ISO 13485, CDSCO, USFDA, QMS, GMP, GDP, and strong analytical, documentation, and communication skills with a passion for regulatory compliance and the pharmaceutical industry.

Industrial trainee — Industrial training - SATMAT PHARMA Pvt. ltd - PUNE Maharashtra

(2024-07 - 2024-07)

• Adhered to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) during industrial training operations
• Gained operational knowledge of production processes, equipment operation, and batch documentation

Industrial trainee — Packaging Department - Mylan laboratories Ltd. - Malegoan MIDC Sinnar Nashik, Maharashtra

(2025-01 - 2025-02)

• Supported primary and secondary packaging operations for high-volume pharmaceutical products while maintaining strict compliance
• Performed in-process checks to ensure packaging quality and compliance.
• Verified batch numbers, manufacturing dates, expiry dates, and labeling accuracy.

Master in Pharmacy - Regulatory Affairs - Dattakala institute of pharmaceutical science and research, pune (2027)

Bachelor of Pharmacy - Ashvin college of pharmacy, sangamner (2025)

Higher Secondary Certificate (HSC) - Science - JSSP college Goveli, kalyan (2021)

Secondary School Certificate (SSC) - Sharda mandir high school, kalyan (2019)