Director of Regulatory Affairs

Job Summary

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