Hybrid Position
Our client is a commercial leader at the forefront of non-opioid pain management and regenerative health solutions. They offer employees the opportunity to make a meaningful impact on healthcare and patient outcomes. Their innovative approach is centered on addressing patients’ unmet pain management needs, contributing to the reduction of opioid reliance in modern medicine.
Position: In this high-visibility role, the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling will lead the review and approval of advertising and promotional activities, collaborate with cross-functional teams, and maintain productive relationships with regulatory agencies.
What You Will Do:
Advertising & Promotion
- Lead the Public Communications Review Committee (PCRC), serving as the regulatory authority for all externally facing materials across commercial and investigational products.
- Develop and own regulatory strategy for advertising and promotional review processes, ensuring compliance with current FDA standards and guidance.
- Serve as the primary RA liaison to commercial, medical affairs, and legal, keeping the organization current on enforcement priorities, regulatory trends, and policy changes.
- Manage all regulatory submissions for promotional materials, including interactions with OPDP.
Labeling
- Own the full labeling lifecycle across USPI, EU PI, and rest-of-world labeling, as well as the Company Core Data Sheet.
- Lead strategic development of core data sheets and product labeling for both commercial and investigational products.
- Represent the company in dealings with FDA’s OPDP and review divisions on labeling matters.
- Coordinate label change submissions with clinical regulatory and drive continuous improvement in labeling business processes.
Leadership
- Build, supervise, and mentor direct reports, identifying growth and development opportunities within the team
- Manage vendors and contractors, support budget and forecasting for the function, and drive lean process improvements across the RA department
What We Are Looking For:
- 10+ years of progressive regulatory affairs leadership in the US pharmaceutical industry.
- Direct experience leading or managing an MLR or PCRC process for promoted prescription drug products.
- Hands-on experience with OPDP submissions and a working knowledge of FDA promotional requirements.
- Demonstrated expertise in USPI development and post-approval labeling management; biologics and/or device experience is a plus.
- Experience managing a team with a track record of developing regulatory talent.
- BS in life sciences required; advanced degree preferred.
- Global regulatory experience (EU, ROW) is preferred.
