Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
Arrowhead Pharmaceuticals
August 30, 2026
Remote friendly (Los Angeles, CA)
United States
Marketing
The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo)
Responsibilities:
- Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across digital, social media, websites, email, print, speaker programs, video testimonials, scientific congresses, and field communications.
- Serve as a core member of MLR meetings; provide clear, practical, risk-based recommendations.
- Advise cross-functional teams on promotional strategy, claims development, fair balance, substantiation requirements, and risk mitigation.
- Manage FDA OPDP/APLB submissions, including timely and accurate FDA 2253 submissions.
- Support review/approval of corporate and external communications.
- Monitor and interpret FDA enforcement trends, OPDP untitled/warning letters, and industry developments.
- Support launch readiness; develop/improve policies, SOPs, guidance, and review standards.
- Collaborate cross-functionally for timely, compliant material development and approvals.
- Mentor junior regulatory staff/consultants and support digital/process optimization initiatives.
Requirements:
- Bachelor’s degree (life sciences, pharmacy, regulatory affairs, or related preferred).
- 7+ years in Regulatory Affairs Advertising & Promotion (pharma/biotech).
- Direct experience leading/reviewing US prescription drug promotional materials.
- Strong working knowledge of FDA-OPDP regulations/guidance, enforcement trends, and MLR processes.
- Working knowledge of PMR requirements in other countries.
- Familiarity with Veeva PromoMats or similar systems.
Preferred:
- Product launch experience; specialty/rare disease/oncology or complex therapeutic area experience; global promotional regulatory experience; fast-paced/emerging biotech experience.
Compensation/Benefits:
- California pay range: $180,000 USD - $200,000 USD.
- Competitive salaries and an excellent benefit package.
Application instruction:
- Candidates must have current, valid authorization to work in the country where the role is located.
Responsibilities:
- Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across digital, social media, websites, email, print, speaker programs, video testimonials, scientific congresses, and field communications.
- Serve as a core member of MLR meetings; provide clear, practical, risk-based recommendations.
- Advise cross-functional teams on promotional strategy, claims development, fair balance, substantiation requirements, and risk mitigation.
- Manage FDA OPDP/APLB submissions, including timely and accurate FDA 2253 submissions.
- Support review/approval of corporate and external communications.
- Monitor and interpret FDA enforcement trends, OPDP untitled/warning letters, and industry developments.
- Support launch readiness; develop/improve policies, SOPs, guidance, and review standards.
- Collaborate cross-functionally for timely, compliant material development and approvals.
- Mentor junior regulatory staff/consultants and support digital/process optimization initiatives.
Requirements:
- Bachelor’s degree (life sciences, pharmacy, regulatory affairs, or related preferred).
- 7+ years in Regulatory Affairs Advertising & Promotion (pharma/biotech).
- Direct experience leading/reviewing US prescription drug promotional materials.
- Strong working knowledge of FDA-OPDP regulations/guidance, enforcement trends, and MLR processes.
- Working knowledge of PMR requirements in other countries.
- Familiarity with Veeva PromoMats or similar systems.
Preferred:
- Product launch experience; specialty/rare disease/oncology or complex therapeutic area experience; global promotional regulatory experience; fast-paced/emerging biotech experience.
Compensation/Benefits:
- California pay range: $180,000 USD - $200,000 USD.
- Competitive salaries and an excellent benefit package.
Application instruction:
- Candidates must have current, valid authorization to work in the country where the role is located.