Job Description

The opportunity

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.

How you’ll spend your day

  • 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.

    • Your experience and qualifications

  • Pharm Dor 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.

    • How We’ll Take Care of You 


    At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. 

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