Director, Global Medical and Promotional Regulatory Affairs

Role Summary

The Director, Global Medical and Promotional Regulatory Affairs will lead the promotional materials review and direct the regulatory aspects of internal and external communications, including advertising and promotional activities in the US. The role provides insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or a specified therapeutic area, working 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. Remote-based opportunity in the United States.

Responsibilities

• Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals.
• 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.
• Presents clear position statement and risk analysis to leaders in the regulatory department, medical affairs and other departments as needed.
• Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product in oncology.
• 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.
• 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.
• Exercise independent leadership skills and regulatory subject matter expertise.
• Work closely with the Promotional Regulatory Affairs lead and other team members to develop regulatory subject matter expertise and leadership skills.
• Provide regulatory support for Medical Affairs Review Committee (MARC).
• Contribute to the development of regulatory strategy through assigned Global Regulatory team.
• 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.

Qualifications

• Required: Substantial pharmaceutical industry experience with proven experience in regulatory affairs advertising and promotion.
• Required: Strong understanding of FDA regulations and guidelines.
• Required: Strong judgment and decision-making skills.
• Required: Excellent collaboration, verbal and written communication skills.
• Preferred: Advanced degree in a scientific discipline (e.g., PharmD) strongly preferred.
• Preferred: Experience with Oncology and new product launch support is strongly preferred.

Education

• Required: B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree).