Amol Sawale
Manager Global Regulatory at Sun Pharmaceutical Ltd.
- Role
- Manager Global Regulatory Affairs at SUN PHARMA
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Amol Sawale
Total 14 years experience in Regulatory Affairs. Results-driven regulatory…
Experience
Manager Global Regulatory Affairs
Dec 2024 — Present · Maharashtra, IN
Handling Submissions activities related to regulatory and semi regulatory markets, Respond to regulatory queries within the stipulated time frame, New DMF, Amendment, Variations, Annual report, Renewal, Site visit, Evaluation of technical documents, Evaluation of Change controls, Life cycle management.
Education
Institute of Pharamceutical Management, Dombivali
Regulatory Affair
2009 — 2010
Padamshri Vithalrao Vikhe patil college of pharmacy, Vilad Ghat, Ahmednagar
B. Pharmacy
2007 — 2009
Skills
- Gcp
- Cleaning Validation
- Regulatory Affairs
- Pharmaceutical Industry
- Sop
- Fda
- Gmp
- Regulatory Submissions
- Ectd
- Ich-Gcp
- V&V
- Validation
- Generic Programming
- Anda
- Glp
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