Vice President I, Regulatory Affairs

• 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.

B. Pharma