Associate Director, Global Medical & Promotional Regulatory Affairs

About the Company

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. With a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments, Jazz is driven by a patient-focused and science-driven approach. The company is headquartered in Dublin, Ireland, with research and development laboratories, manufacturing facilities, and employees in multiple countries committed to serving patients worldwide.

About the Role

The Associate Director, Global Medical and Promotional Regulatory Affairs will lead promotional materials review activities and direct the regulatory aspects of internal and external communications, including advertising and promotional activities in the U.S. This role involves providing insight, judgment, and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or other therapeutic areas. The Associate Director will work autonomously and collaboratively with Regulatory, Medical, Legal/Compliance, and Commercial organizations to ensure compliance with regulations and company policies while supporting business objectives.

Responsibilities

• Lead the Promotional Material Review Committee (PMRC) for assigned products/therapeutic areas in the U.S. for Jazz Pharmaceuticals.
• Provide input on decisions regarding concepts and draft promotional materials to satisfy FDA promotional regulations, corporate standards, policies, and business objectives.
• Serve as the Promotional Regulatory Affairs lead for new product launches, contributing to the U.S. Core launch team for assigned products.
• Provide regulatory advice and support to the organization, managing the PMRC process and regulatory aspects of review and approval for promotional materials.
• Maintain compliance of promotional materials with FDA regulations and submit them to the Office of Prescription Drug Promotion (OPDP) in a timely fashion.
• Further develop independent leadership skills and regulatory subject matter expertise.
• Chair review meetings, leading discussions and collaborating with cross-functional reviewers to determine next steps and approval status.
• Ensure content, quality, accuracy, and format of submissions comply with applicable internal policies, procedures, FDA guidance, and regulations.
• Partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing, and other departments to ensure thorough, timely, and efficient review of all materials.
• Provide regulatory support for the Medical Affairs Review Committee (MARC) and publications review.
• Contribute to the development of regulatory strategy through the assigned Global Regulatory team.
• Provide guidance and expertise on new marketing concepts and promotional tactics for assigned product(s).
• Lead interactions with FDA/OPDP for assigned product(s), including submission of materials for advisory comments for full approval and accelerated approval products.
• Develop depth and current awareness of evolving FDA regulations, interpretations, advisory comments, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry.
• Interpret and communicate the FDA perspective to relevant stakeholders and recommend policy and/or process changes as needed.

Requirements

• B.S. or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience may complement the degree). Direct experience in advertising and promotional material review (Regulatory or otherwise) is required.
• Advanced degree in a scientific discipline (e.g., PharmD) is strongly preferred.
• Substantial, increasingly responsible experience in the pharmaceutical industry.
• Strong understanding of FDA regulations and guidelines.
• Strong judgment and decision-making skills.
• Excellent collaboration, verbal, and written communication skills.

Pay

The full and complete base pay range for this role is $160,000.00 - $240,000.00. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. Internal equity considerations will also influence individual base pay decisions. This range is reviewed regularly.

Benefits

• Discretionary annual cash bonus or incentive compensation, depending on the role and in accordance with the Company’s Global Cash Bonus Plan or Incentive Compensation Plan.
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.
• Medical, dental, and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.

For more information on benefits, visit Jazz Pharmaceuticals Benefits.