Director Regulatory Affairs- US post approvals

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 314.70), 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.

komal@topgearconsultants.com