Associate Director, Global Medical & Promotional Regulatory Affairs

The Associate Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group and will be leading the promotional materials review activities; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area.

The Associate Director works autonomously and collaboratively with Regulatory, Medical, Legal/Compliance and Commercial organizations. The individual develops and applies expertise to ensure promotional programs and tactics are compliant with regulations and company policies while supporting the achievement of business objectives.

• Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals. Under the direction of the US lead Promotional Regulatory Affairs, provides input on decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectives.
• As needed may serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product.
• Provide regulatory advice, and support to the organization. Lead the PMRC process and manage regulatory aspects of the review and approval for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials 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 by leading discussion of the material being discussed and collaborating with other cross-functional reviewers to determine next steps and approval status.
• Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures as well as FDA guidance and regulations.
• Effectively partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materials.
• Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review.
• Contribute to the development of regulatory strategy through 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.
• Further develop depth and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Interprets and communicates FDA perspective to relevant stakeholders and recommends policy and/or process changes as needed, consulting with Regulatory colleagues as appropriate.

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