Deepak Patil
Deputy General Manager @USV PRIVATE LIMITED
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WORK HISTORY
Deputy General Manager @USV PRIVATE LIMITED
Mumbai, IN
Heading US RA team and responsible for new filing, Post approval variations and Life cycle management
EDUCATION
Bharati Vidyapeeth
B. Pharm
NDMVP Samaj College of pharmacy, Nashik
M. Pharm, Pharmaceutical Chemistry
SKILLS
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.
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