Director of Regulatory Affairs Advertising and Promotions
Company Summary:
My client, a leading global pharmaceutical company focuses on expanding access to quality treatment options for a wide variety of therapeutic areas from cardiovascular health and infectious diseases to oncology. My client is looking to add a Regulatory Affairs Advertising and Promotions Director to their team! This role will be fully remote!
The Director of Regulatory Affairs Ad/Promo will be responsible for:
- Providing regulatory expertise relating to US regulations and strategic leadership/oversight to Advertising and Promotion activities within the assigned therapeutic area
- Acting as the Regulatory Ad/Promo subject expert on strategies and product launch materials through identification and resolution of issues
- Communicating and negotiating directly with the OPDP on Ad/Promo material on requests for advisory comments
- Maintaining partnerships with internal business stakeholders including Global Regulatory leaders, medical affairs, product safety, legal, marketing, and business development
- Identifying areas for development of efficiencies for Ad/Promo processes for the MARC and SMART processes
- Reviewing marketing materials intended for internal and external audiences that would be impacted by advertising and promotion regulations
The Director of Regulatory Affairs Ad/Promo should have the following qualifications:
- Bachelor's degree and 5+ years of Regulatory Affairs experience with expertise in Ad/Promo
- Expert knowledge of FDA and regulatory guidance pertaining to Ad/Promo for pharmaceutical products
- Excellent written and verbal communication skills as needed to directly supervise employees
