Dir Regulatory Affairs

The Director, Regulatory Affairs Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U. S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners.

• 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.

• 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.