Director of Regulatory Affairs

Providing regulatory oversight and strategic guidance on promotional communications for assigned marketed products, the full-time remote Director of Regulatory Affairs will manage the regulatory review process, collaborate with cross-functional teams, and ensure compliance with applicable regulations in North America. Key responsibilities Oversee the regulatory review process for promotional materials to ensure compliance with local regulations and company policies Provide strategic guidance on commercial product labeling and serve as the lead regulatory representative on cross-functional teams Advise on healthcare regulations and assist in developing policies related to promotional and non-promotional communications Required qualifications Bachelor's degree in a scientific or health-related discipline 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 5 years in a Regulatory Advertising/Promotion capacity Direct experience with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred Experience in oncology or relevant therapeutic areas is preferred Proficiency in MS Office Suite and document management systems; experience with Veeva Vault is preferred