Anupam Dutt

About Anupam Dutt

Strategic Regulatory Affairs Professional with over 25 years of extensive experience in driving US market authorizations and life cycle management for diverse pharmaceutical portfolios. Expert in navigating complex FDA pathways, including NDA 505(b)(2) and ANDA (Rx and OTC) submissions, with a proven track record in securing approvals for high-barrier dosage forms such as Solid and Liquid Orals (IR/MR), Nasal, Topical, MDI and Transdermal. Core Competencies & Impact: Submissions & Technical Writing: Mastery of CMC writing and review, ensuring technical integrity and data compliance for eCTD filing of original applications and life cycle maintenance. Regulatory Strategy: Specialized in executing post-approval strategies, including CBE, CBE-30, PAS, and Group Supplements, to maintain product marketability and compliance. Compliance & Risk Management: Expert in Change Control assessment, regulatory compliance auditing, and crafting robust Query Responses to FDA IRs and CRLs to expedite approval timelines. Life Cycle & Portfolio Management: Proficient in Due Diligence for ownership transfers (mergers/acquisitions) and managing the end-to-end life cycle of mature product portfolios. A results-oriented professional dedicated to bridging the gap between complex formulation development and stringent USFDA regulatory requirements.

Experience

1. VP Regulatory Affairs, Us Mkt

   Aurobindo Pharma Ltd

   Jan 2021 — Present · IN

Education

• Institute of Management Studies (IMS), Indore

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Skills

• Gmp
• Regulatory Requirements
• Standard Operating Procedure (Sop)
• Regulatory Affairs
• Validation
• Change Control
• Ectd
• Capa
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Sop
• Fda
• Quality Assurance
• Anda
• Regulatory Submissions
• Strategy
• Cleaning Validation
• Pharmaceutics