Director Regulatory Affairs- US post approvals

4 days ago

Mumbai Mumbai Suburban Navi Mumbai, India Topgear Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Opening with a leading Pharma company for their office in Navi Mumbai

Role: Director Regulatory Affairs - US post approvals

Experience: 15 Years+

Role & responsibilities :

Essential Duties & Responsibilities:

  • Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations.

  • Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including:

  • CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences

  • Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams.

  • Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.
  • Establish and maintain strong relationships with FDA project managers.
  • Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes.
  • Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization.
  • Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning.
  • Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives.
  • Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book.

Position Requirements:

  • Pharm D or M. Pharma in a scientific discipline.
  • Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products.
  • Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.
  • Deep expertise and applied knowledge of FDA regulations (21 CFR , ICH guidelines, and eCTD submission standards.
  • Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree).
  • Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs.
  • Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance.
  • Demonstrates a basic understanding of pharmaceutical drug development.
  • Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills.
  • Demonstrates excellent verbal and written communication skills.
  • Experience working in a matrixed, multinational environment, as well as with third parties.
  • Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus.
  • Lean Six Sigma certification, or other accreditation related to improving business processes is a plus.

Interested candidate share resume

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