San Diego, California
Competitive - Above Market Average
BD - 295
4 months ago
Director Regulatory Affairs, Advertising & Promotion
Location: San Diego, California
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package. Remote Consideration.
Excellent opportunity to spearhead and own the Advertising/Promotion function with my client as they look to move to commercialization with their leading oncology candidate. Excellent clinical company with an incredible pipeline and amazing financial stability!
This person will be the direct lead for the reviewing and approving of all promotional/non promotional materials for products to ensure compliance with FDA regulations and guidelines. This position requires an ability to understand and evaluate all perspectives of promotions and advertising and provide clear regulatory guidance.
- Internal expert on global regs (FDA, EMA, PMDA etc) and guidance on trends governing the promotion of pharmaceutical products
- Understand and evaluate all perspectives of promotions and advertising while providing clear regulatory guidance
- Act as primary contact with FDA’s Office of Prescription Drug Promotion
- Lead and manage Materials Review Committee (MRC) meetings and collaborate with internal/external teams
- Interacting with commercial, medical, and legal teams to ensure compliance
- Keeping current with industry and regulatory developments relating to advertising and promotion, including interpretation of FDA enforcement letters, interpretation of new and updated Guidance Documents for Industry, and, as applicable, evaluating related internal policies/best practices and processes.
- BS/BA necessary, graduate degree preferred
- Min of 8 years of biopharma experience, at least 5 years in Regulatory Affairs within Ad/Promo
- Complete Understanding of US law and regulations in related to communications about prescription drugs and investigational treatment
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (619) 784 9869.