Director, Global Medical and Promotional Regulatory Affairs

Role Summary

Director, Global Medical and Promotional Regulatory Affairs is a leadership role within Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group. The position directs the regulatory aspects of internal and external communications, including advertising and promotional activities in the US, and provides insight, judgment, and decision-making on promotional and non-promotional programs for assigned products in oncology or other therapeutic areas. The role requires autonomous and collaborative work with Regulatory, Medical, Legal/Compliance, and Commercial teams 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 US.
• Provide input on decisions regarding concepts and draft promotional materials to meet FDA promotional regulations, corporate standards, policies, and business objectives.
• Present clear position statements and risk analyses to leaders in regulatory, medical affairs, and other departments as needed.
• Serve as the Promotional Regulatory Affairs lead for a new product launch, contributing to the US Core launch team for the assigned product in oncology.
• Provide regulatory advice and support to the organization.
• Lead the PMRC process and manage regulatory aspects of review and approval for product promotional materials; ensure compliance with FDA regulations and submit materials to the Office of Prescription Drug Promotion (OPDP) in a timely fashion.
• Partner with Regulatory, Medical Affairs, Legal/Compliance, Marketing, and other departments to ensure thorough, timely, and efficient review of all materials.
• Exercise independent leadership and regulatory subject matter expertise.
• Collaborate with the Promotional Regulatory Affairs lead and team members to develop regulatory subject matter expertise and leadership skills.
• Provide regulatory support for Medical Affairs Review Committee (MARC).
• Contribute to regulatory strategy development within the Global Regulatory team.
• Lead interactions with FDA/OPDP for assigned products, including submission of materials for advisory comments for full and accelerated approvals.
• Maintain current knowledge of evolving FDA regulations, advisory comments, enforcement letters, and policy issues; interpret and communicate FDA perspectives and recommend policy/process changes in consultation with Regulatory colleagues.

Qualifications

• B.S. or B.A. in a scientific discipline or equivalent; non-scientific degrees with relevant industry experience acceptable.
• Advanced degree in a scientific discipline (e.g., PharmD) strongly preferred.
• substantial pharmaceutical industry experience with proven experience in regulatory affairs advertising and promotion; oncology and new product launch experience strongly preferred.
• Strong understanding of FDA regulations and guidelines.
• Strong judgment and decision-making skills.
• Excellent collaboration, verbal, and written communication skills.