Vice President I, Regulatory Affairs

RXinsider LTD.; Ahmedabad District; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

RXinsider LTD. seeks a senior Regulatory Affairs leader to head a 70+ member RA organization and steer global regulatory strategies across multiple markets.

You will guide submissions, lifecycle management, and collaborations with cross-functional teams to ensure compliance with FDA, EMA, Health Canada and ICH guidelines. The role requires strategic vision, strong leadership, and the ability to coordinate Pre-ANDA, Pre-IND, Pre-NDA, and post-approval activities, while driving continuous

Qualifications

• B. Pharma degree required.
• Experience leading a large Regulatory Affairs organization (70+ members).
• Experience with US, Canada, and EU regulatory submissions.
• Proven ability to drive strategy and lifecycle management.

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.
• Lead activities related to Pre-ANDA, Pre-IND, Pre-NDA, Post-approval submissions, ANDA filings, 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.

Education

B. Pharma

Job description

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:
  • Pre-ANDA submissions
  • Pre-IND interactions
  • Pre-NDA activities
  • Post approval submissions
  • ANDA filings
  • 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