Senior Director, Regulatory Affairs & Quality
My client, a commercial-stage pharmaceutical company focuses on developing some of the most successful dermatology products in the industry! My client is looking to add a fully remote Senior Director of Regulatory Affairs & Quality to the team - the role is more focused on the regulatory side!
The Senior Director of Regulatory Affairs & Quality will be responsible for:
- Assuring that projects are assigned to appropriate team members to meet goals, FDA timelines, and to ensure the team meets all company objectives
- Acting as hands-on leader in regard to daily workload and providing leadership in preparation of NDA submission documents including CMC, clinical, labeling, annual reports and 510ks.
- Acting as the liaison with the OPDP for assigned products to facilitate the FDA review of ad/promo materials
- Reviewing and submitting annual reports and product safety reports
The Senior Director of Regulatory Affairs & Quality should have the following qualifications:
- 12-15 years of experience in regulatory, quality, and/or pharmacovigilance environment
- 12-15 years of experience in the pharmaceutical and/or medical device industry
- Strong knowledge of FDA regulations and guidelines