• Lead and manage a large Regulatory Affairs organization comprising 70+ team
members across multiple regulatory functions. • Define global regulatory
strategies and make critical regulatory decisions aligned with business
objectives. • Provide strategic guidance, technical direction, and regulatory
support to RA teams and cross functional stakeholders. • Drive regulatory
submissions and lifecycle management activities for the US, Canada, and EU
markets. • Ensure regulatory strategies and submissions meet expectations of
FDA, EMA, Health Canada, and ICH guidelines. • Lead activities related to: o
Pre-ANDA submissions o Pre-IND interactions o Pre-NDA activities o Post approval
submissions o ANDA filings o 505(b)(2) NDA submissions • Ensure compliance with




GDUFA and PDUFA commitments and timelines. • Continuously improve submission
quality, reduce regulatory deficiencies, and enhance first-cycle approval rates.
• Collaborate with R&D;, Quality, Clinical, Pharmacovigilance, Supply Chain, and
Commercial teams for regulatory planning and execution. • Represent Regulatory
Affairs during inspections, audits, health authority interactions, and strategic
business discussions. • Drive process optimization, regulatory intelligence, and
operational excellence initiatives within the RA function.

QUALIFICATIONS

B. Pharma

📌 Vice President I, Regulatory Affairs Ahmedabad
🏢 Amneal
📍 Ahmedabad