Minal Jain

About Minal Jain

I am a highly motivated and goal-oriented professional, actively seeking opportunities to expand my knowledge and advance in the regulatory affairs. With a proactive and innovative mindset, I continuously explore new approaches to drive improvement. My strong organizational skills and dedicated work ethic support my commitment to delivering quality outcomes and contributing meaningfully to patient care and well-being.

Experience

1. Regulatory Affairs

   Lupin

   Apr 2025 — Present · Pune, IN

   Assisted in biosimilar regulatory filings for Domestic and global markets (USA and Europe) in compliance with CDSCO, USFDA and EMA guidelines. Prepared and compiled Modules of Administrative, summaries, CMC and nonclinical sections for submissions of NDA (CDSCO) and BLA (USFDA). Assist in preparing, reviewing and compiling regulatory dossier (CTD/eCTD format). Contributed to regulatory applications and submissions with authorities such as DCGI(CLA), RCGM and SLA. Supported filing of applications for product approvals and renewals. Supported change control activities by reviewing regulatory documents to ensure compliance. Coordinated with cross-functional teams for collecting CMC, non-clinical, and clinical documentation.

Education

• Padmashri D.Y.Patil Pratishthans Padamshri Dr.D.Y.Patil Arts, Scienec & Commerce College, Pimpri, Pune 18.

  Master's degree, Biotechnology

• Shri samartha junior college of science akola

  Higher secondary, Physics chemistry biology

• Shri Shivaji Arts, Commerce & Science, College, Akola.

  Bachelor's degree, Biotechnology