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