Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)

Responsibilities

• Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others.
• Participate as a core member of MLR meetings and provide clear, practical, and risk-based regulatory recommendations.
• Confidently advise cross-functional teams on promotional strategy, claims development, fair balance, substantiation requirements, and risk mitigation.
• Manage all submissions to FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), including the timely and accurate FDA 2253 submissions of US promotional materials.
• Support review and approval of corporate and external communications, as applicable.
• Monitor and interpret evolving FDA enforcement trends, OPDP untitled/warning letters, and relevant industry developments to proactively advise internal stakeholders.
• Support launch readiness activities
• Contribute to the development and continuous improvement of internal policies, SOPs, guidance documents, and review standards.
• Collaborate effectively across functions to support timely and compliant material development and approvals.
• Provide mentorship and guidance to junior regulatory staff or consultants, as applicable.
• Participate in cross-functional initiatives related to process optimization, digital innovation, and operational excellence.

Requirements

• Bachelor’s degree required; degree in life sciences, pharmacy, regulatory affairs, or related scientific discipline preferred.
• 7+ years of experience in Regulatory Affairs Advertising & Promotion within the pharmaceutical or biotechnology industry.
• Direct Experience leading or reviewing US prescription drug promotional materials required.
• Strong working knowledge of FDA-OPDP regulations and guidance governing pharmaceutical advertising and promotion, enforcement trends, and MLR processes and procedures.
• Working knowledge of PMR requirements in other countries.
• Familiarity with Veeva PromoMats or similar review systems.
• Preferred: Product launch experience, experience supporting specialty, rare disease, oncology, or other complex therapeutic areas, global promotional regulatory experience, experience working in fast-paced or emerging biotech environments.

Pay

California pay range: $180,000 USD - $200,000 USD