Director, Regulatory Advertising and Promotion

Job Summary:

We are currently searching for a skilled professional to join a well-known client’s team as a Remote Director, Regulatory Advertising and Promotion. The successful candidate will serve as the lead Regulatory reviewer in our Promotional Review Committee (PRC) and collaborate across cross-functional teams to guide strategy and ensure alignment with FDA regulations and guidance. This fully remote role offers a dynamic opportunity to work at the forefront of rare disease therapies in a fast-paced, collaborative environment.

Key Responsibilities:

• Lead regulatory strategy and execution for promotional and non-promotional materials in compliance with FDA regulations.
• Provide regulatory input on new product launches, label updates, disease state education, field training, and external communications.
• Represent Regulatory Affairs in PRC and MRC, reviewing branded and unbranded content for consistency with approved labeling.
• Submit materials to OPDP/APLB and manage pre-submission requirements, particularly for accelerated approval products.
• Interpret FDA feedback and provide clear, timely communication to internal stakeholders.
• Collaborate with Medical, Legal, Commercial, Regulatory Operations, and other cross-functional teams to ensure compliant, timely submissions and feedback implementation.
• Monitor regulatory environment and enforcement trends, delivering training to PRC teams and stakeholders.
• Lead updates to internal SOPs, best practices, and review policies.

Qualifications:

• Bachelor’s degree or equivalent with 12+ years of relevant experience
• Expertise in promotional review for rare disease and accelerated approval products preferred
• Strong experience representing Regulatory in PRC teams and consulting with OPDP/APLB
• Proven leadership and collaboration across cross-functional teams
• Excellent communication, negotiation, and problem-solving skills
• Ability to influence without authority and navigate complex regulatory scenarios
• Proficiency in Microsoft Office, Veeva, and other regulatory platforms
• Ability to manage multiple priorities in a fast-paced, matrixed environment
• Highest standards of ethics, quality, and accountability