Deepak Patil
Deputy General Manager- Regulatory Affairs at USV Private Limited.
- Role
- Deputy General Manager at USV PRIVATE LIMITED
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Deepak Patil
18+ yrs experience in Regulatory Affairs with reputed company like Indoco, Mylan, USV, Alkem.Heading Regulatory team for USA market. Well versed with the filing requirements of Tablets, Capsules, Solution/Suspension, Creams, Nasal Spray, Parenteral Dosage Forms and ophthalmic product for US, Australia/ New Zealand Market.Hands on experience in electronic submissions (E-CTD). Timely submission of Deficiencies (IR, CRL, ECD and DRL) received from Agency.Control correspondence, suitability petition filling.Handling of Post approval changes such as CBE, CBE-30, Prior Approval Supplements, Annual reports etc.Labeling preparations for US market including Structured Product Labeling (SPL). SpecialtiesANDA Submissions, Product Lifecycle Management, Handling Variations/Supplements, Drug Listings, cGMP Compliance.
Experience
Deputy General Manager
Nov 2024 — Present · Mumbai, IN
Heading US RA team and responsible for new filing, Post approval variations and Life cycle management
Education
Bharati Vidyapeeth
B. Pharm
2001 — 2005
NDMVP Samaj College of pharmacy, Nashik
M. Pharm, Pharmaceutical Chemistry
2006 — 2008
Skills
- Fda
- Pharmaceutical Development
- Dissolution
- Regulatory Submissions
- Regulatory Requirements
- Drug Delivery
- Ich Guidelines
- Cmc
- Gmp
- Glp
- Product Development
- Pharmaceutics
- Anda
- Andas
- Regulatory Affairs
- Generic Programming
- Ectd
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