[Hiring] Associate Director, Global Medical and Promotional Regulatory Affairs @Jazz Pharmaceuticals

Role Description

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. The role involves:

• Directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US.
• Providing insight, judgment, and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area.
• Working autonomously and collaboratively with Regulatory, Medical, Legal/Compliance, and Commercial organizations.
• Ensuring promotional programs and tactics are compliant with regulations and company policies while supporting the achievement of business objectives.

Essential Job Functions:

• Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US.
• Provide input on decisions regarding concepts and draft promotional materials to satisfy FDA promotional regulations, corporate standards, and business objectives.
• Serve as the Promotional Regulatory Affairs lead for a new product launch as needed.
• Provide regulatory advice and support to the organization.
• Manage regulatory aspects of the review and approval for product promotional materials.
• Maintain compliance of promotional materials with FDA regulations and submit materials to the Office of Prescription Drug Promotion (OPDP) in a timely fashion.
• Chair review meetings and collaborate with cross-functional reviewers to determine next steps and approval status.
• Ensure compliance of submissions with internal policies and FDA guidance.
• Partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing, and other departments for efficient material review.
• 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 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.
• Develop depth and awareness of evolving FDA regulations and communicate FDA perspectives to stakeholders.

Qualifications

• B.S or B.A. degree in a scientific discipline or equivalent.
• 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.

Benefits

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

Company Description

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases. The company has a diverse portfolio of marketed medicines and is headquartered in Dublin, Ireland.