Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
$180,000–$200,000 year
On-sitePasadena, California, United States
Job Summary
Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) leads regulatory review and strategic guidance for US promotional materials across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications. Serves as a core member of MLR meetings, provides risk-based regulatory recommendations, and advises cross-functional teams on promotional strategy, claims development, substantiation requirements, and risk mitigation. Manages FDA submissions to OPDP and APLB, including timely 2253 submissions; supports review and approval of corporate and external communications; monitors FDA enforcement trends and industry developments to proactively advise stakeholders; supports launch readiness activities; contributes to internal policies, SOPs, and review standards; collaborates across functions to ensure timely, compliant material development and approvals; provides mentorship to junior regulatory staff or consultants; participates in cross-functional initiatives related to process optimization, digital innovation, and operational excellence.
Required Qualifications
- 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
- California pay range
- Arrowhead provides competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.
- California Applicant Privacy Policy
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