California Licensed Regulatory Affairs Director

Job Summary

The California Licensed Regulatory Affairs Director will lead promotional materials review activities and manage regulatory aspects of internal and external communications in a full-time remote role, ensuring compliance with FDA regulations and corporate policies while supporting business objectives.

Key responsibilities

• Lead the promotional material review committee for assigned products, ensuring compliance with FDA regulations and corporate standards
• Provide regulatory advice and support for product promotional materials, managing the review and approval process
• Collaborate with cross-functional teams to develop regulatory strategies and maintain compliance across promotional tactics

Required qualifications

• B.S. or B.A. degree in a scientific discipline or equivalent, with substantial experience in the pharmaceutical industry
• Direct experience in advertising and promotional material review is required; advanced degree (e.g., PharmD) is strongly preferred
• Strong understanding of FDA regulations and guidelines
• Proven judgment and decision-making skills
• Excellent collaboration and communication skills