Associate Director, Global Medical & Promotional Regulatory Affairs
Jazz Pharmaceuticals
August 20, 2026
Remote friendly (California, United States)
United States
Medical Affairs
Associate Director, Global Medical and Promotional Regulatory Affairs
Essential Job Functions
- Lead the Promotional Materials Review Committee (PMRC) for assigned products/therapeutic areas in the US; provide input on concepts and draft promotional materials to meet FDA promotional regulations, corporate standards/policies, and business objectives.
- Serve as Promotional Regulatory Affairs lead for new product launches as needed (contributions to US Core launch team).
- Provide regulatory advice and support; lead PMRC process, manage review/approval of promotional materials, ensure compliance with FDA regulations, and submit materials to OPDP in a timely fashion.
- Chair review meetings; lead discussion, collaborate with cross-functional reviewers to determine next steps/approval status.
- Ensure submission content, quality, accuracy, and format comply with internal policies/procedures and FDA guidance/regulations.
- Partner with Regulatory, Medical Affairs, Legal/Compliance, Marketing, and other departments to ensure thorough, timely, efficient material review.
- Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review.
- Contribute to regulatory strategy for the assigned Global Regulatory team.
- Provide guidance on new marketing concepts and promotional tactics.
- Lead FDA/OPDP interactions, including advisory comment submissions for full approval and accelerated approval products.
- Stay current on evolving FDA regulations/interpretations, enforcement letters, and policy issues; communicate FDA perspective and recommend policy/process changes.
Required/Preferred Education and Licenses
- BS/BA in a scientific discipline or equivalent plus substantial increasingly responsible pharmaceutical industry experience; direct advertising/promotional material review experience required. PharmD or other advanced scientific degree strongly preferred.
- Strong understanding of FDA regulations and guidelines.
- Strong judgment and decision-making; excellent collaboration and verbal/written communication.
US Candidates Only (Pay and Benefits)
- Base pay range: $160,000–$240,000.
- Eligible for discretionary annual cash bonus/incentive and discretionary equity grants.
- Eligible for medical, dental, vision, 401k, and flexible paid vacation.
Essential Job Functions
- Lead the Promotional Materials Review Committee (PMRC) for assigned products/therapeutic areas in the US; provide input on concepts and draft promotional materials to meet FDA promotional regulations, corporate standards/policies, and business objectives.
- Serve as Promotional Regulatory Affairs lead for new product launches as needed (contributions to US Core launch team).
- Provide regulatory advice and support; lead PMRC process, manage review/approval of promotional materials, ensure compliance with FDA regulations, and submit materials to OPDP in a timely fashion.
- Chair review meetings; lead discussion, collaborate with cross-functional reviewers to determine next steps/approval status.
- Ensure submission content, quality, accuracy, and format comply with internal policies/procedures and FDA guidance/regulations.
- Partner with Regulatory, Medical Affairs, Legal/Compliance, Marketing, and other departments to ensure thorough, timely, efficient material review.
- Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review.
- Contribute to regulatory strategy for the assigned Global Regulatory team.
- Provide guidance on new marketing concepts and promotional tactics.
- Lead FDA/OPDP interactions, including advisory comment submissions for full approval and accelerated approval products.
- Stay current on evolving FDA regulations/interpretations, enforcement letters, and policy issues; communicate FDA perspective and recommend policy/process changes.
Required/Preferred Education and Licenses
- BS/BA in a scientific discipline or equivalent plus substantial increasingly responsible pharmaceutical industry experience; direct advertising/promotional material review experience required. PharmD or other advanced scientific degree strongly preferred.
- Strong understanding of FDA regulations and guidelines.
- Strong judgment and decision-making; excellent collaboration and verbal/written communication.
US Candidates Only (Pay and Benefits)
- Base pay range: $160,000–$240,000.
- Eligible for discretionary annual cash bonus/incentive and discretionary equity grants.
- Eligible for medical, dental, vision, 401k, and flexible paid vacation.