- 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 Pharmaceuticals
📍 Ahmedabad