Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
Arrowhead Pharmaceuticals
June 26, 2026
Remote friendly (Los Angeles, CA)
United States
Corporate Functions
The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) partners cross-functionally with Marketing, Medical, Legal, Market Access, Corporate Communications, and other stakeholders to ensure materials are compliant with country/local regulations, industry standards, and company policies while supporting business objectives.
Responsibilities:
- Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels.
- Serve as a core member of MLR meetings and 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 and APLB submissions, including timely and accurate FDA 2253 submissions of US promotional materials.
- Support review and approval of corporate and external communications.
- Monitor and interpret FDA enforcement trends, OPDP untitled/warning letters, and industry developments; advise internal stakeholders.
- Support launch readiness activities.
- Contribute to internal policies, SOPs, guidance documents, and review standards.
- Collaborate to support timely, compliant material development and approvals.
- Mentor junior regulatory staff or consultants (as applicable).
- Participate in cross-functional process optimization, digital innovation, and operational excellence initiatives.
Requirements:
- Bachelor’s degree required; life sciences/pharmacy/regulatory affairs preferred.
- 7+ years Regulatory Affairs Advertising & Promotion experience in pharma/biotech.
- Direct experience leading or reviewing US prescription drug promotional materials.
- Strong 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 review systems.
Preferred:
- Product launch experience.
- Specialty/rare disease/oncology or other complex therapeutic area experience.
- Global promotional regulatory experience.
- Experience in fast-paced or emerging biotech environments.
California pay range: $180,000–$200,000 USD.
Responsibilities:
- Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels.
- Serve as a core member of MLR meetings and 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 and APLB submissions, including timely and accurate FDA 2253 submissions of US promotional materials.
- Support review and approval of corporate and external communications.
- Monitor and interpret FDA enforcement trends, OPDP untitled/warning letters, and industry developments; advise internal stakeholders.
- Support launch readiness activities.
- Contribute to internal policies, SOPs, guidance documents, and review standards.
- Collaborate to support timely, compliant material development and approvals.
- Mentor junior regulatory staff or consultants (as applicable).
- Participate in cross-functional process optimization, digital innovation, and operational excellence initiatives.
Requirements:
- Bachelor’s degree required; life sciences/pharmacy/regulatory affairs preferred.
- 7+ years Regulatory Affairs Advertising & Promotion experience in pharma/biotech.
- Direct experience leading or reviewing US prescription drug promotional materials.
- Strong 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 review systems.
Preferred:
- Product launch experience.
- Specialty/rare disease/oncology or other complex therapeutic area experience.
- Global promotional regulatory experience.
- Experience in fast-paced or emerging biotech environments.
California pay range: $180,000–$200,000 USD.