dynetherapeutics
Executive Director, Regulatory Affairs Advertising & Promotion
At a Glance
- Location
- Waltham, Massachusetts, United States
- Experience
- 12+ years
- Posted
- 2026-02-25T00:01:00-05:00
Key Requirements
Required Skills
Domain Knowledge
- Advertising
- Biotech
- Clinical
- Education
- Medical
- Pharmaceutical
- Regulatory
Requirements
12+ years pharmaceutical/biotech industry experience with a minimum of 10 years of
irect experience as primary Regulatory reviewer of advertising and promotional materials is
In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising & promotion
Successful launch experience, preferably including global product launches
of implementing successful business strategies for branded and unbranded promotional campaigns
Ability to see impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities.
Responsibilities
The Executive Director, Regulatory Affairs Advertising & Promotion leads regulatory strategy and compliance for advertising and promotional activities across all external communications. This role serves as the subject matter expert, partnering with the launch team, commercial, medical affairs, R&D, corporate communications, legal, and leadership to ensure messaging aligns with FDA regulations and company objectives. The person in this role provides strategic guidance on complex promotional claims, anticipates market and regulatory factors, and drives innovative, compliant solutions. This role chairs the regulatory review for the Promotion Review Committee (PRC) and for the Medical Review Committee (MRC), balancing legal requirements with business goals while mitigating risk across promotional campaigns and corporate communications.
ubject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives
and evaluates fundamental issues, providing strategy and
factors that could influence strategies and company position in the market
to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance
erves as lead Regulatory Advertising & Promotion expert on