Job Description

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

Recommended Jobs