Prasad Landge
Deputy Manager - US Regulatory Affairs
- Role
- Deputy Manager at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prasad Landge
Pharmaceutical Regulatory specialist with formulation development background. …
Experience
Deputy Manager
Jul 2024 — Present · Mumbai, IN
Pre-IND, IND submissions, Pre-ANDA, ANDA, NDA, 505(b)(2) submissions- Response to the DRL, IR, CRL deficiencies- Post approval life cycle management submissions with change control evaluation such as CBE-0, CBE-30, PAS amendments and the Annual Reports- Product correspondences, controlled correspondences for complex generics, solid orals, injectables, respiratory dosage forms- Preparation of regulatory strategy and providing regulatory support to RnD, unit teams- Regional submissions such as PLAIR submissions, promotional material submissions, drug listing/delisting, labeling amendments, Patent certification amendments- Launch triaging and support for product launch activities - Regulatory support to units for the USFDA inspections.
Education
L. H. Hiranandani College of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
Vivekanand Education Society's College of Pharmacy
Master's Degree, pharmaceutics
2014 — 2016
Skills
- Pharmaceutical Industry
- Abbreviated New Drug Application (Anda)
- Microsoft Office
- Pharmaceutics
- Microsoft Excel
- Formulation Development
- Technology Transfer
- Formulation
- Cgmp Manufacturing
- Drug Delivery
- Manufacturing Scale-Up
- Regulatory Affairs
- Pharmacology
- Research
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