Regulatory Affairs – Advertising & Promotion Lead
Onsite 4 days/week in San Diego

An emerging commercial-stage neuro biotech is seeking an experienced Regulatory Affairs professional with a strong leadership presence and deep expertise in independent review of promotional and medical materials within a biotech or pharmaceutical environment. This role leads cross?functional promotional review activities and provides strategic regulatory guidance to support compliant and effective product communications.

Key Responsibilities

• Lead and facilitate Promotional Review Committee (PRC) activities for assigned products
• Independently review promotional, medical, and disease?state materials and provide clear, risk?based regulatory guidance
• Partner with cross?functional teams to support compliant launch and post?launch strategies
• Assess regulatory risk, interpret evolving guidance, and ensure alignment with applicable regulations and internal standards
• Manage timely submissions of promotional materials to regulatory authorities
• Contribute to process improvements and support team development as needed

Qualifications

• Strong leadership presence with proven experience independently reviewing promotional materials
• Prior experience leading or co?leading a PRC 
• Background in biotech or pharma is required
• Launch experience is a plus
• Rare disease experience is beneficial but not required
• Solid understanding of FDA advertising & promotion regulations and review processes
• Excellent communication, collaboration, and organizational skills