Vice President I, Regulatory Affairs

Amneal; Gujarat; On-site; INR 3,000,000 - 8,000,000; Full time

Job summary

Amneal in Gujarat, India seeks a senior Regulatory Affairs leader to manage a 70+ person team and shape global regulatory strategies. You will drive submissions for the US, Canada, and EU markets and provide strategic guidance to RA and cross-functional partners.

You will ensure compliance with FDA, EMA, Health Canada, ICH guidelines, and timelines, while leading inspections and lifecycle management initiatives to improve submission quality and first-cycle approvals.

Responsibilities

• 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.
• 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.

Job description

ROLE

• – 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.


• – 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.