Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
Arrowhead Pharmaceuticals
August 09, 2026
Remote friendly (Los Angeles, CA)
United States
Corporate Functions
The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) is a strategic role that partners cross-functionally to ensure promotional 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.
- Participate 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/APLB submissions, including timely and accurate FDA 2253 submissions.
- Support review and approval of corporate and external communications (as applicable).
- Monitor and interpret FDA enforcement trends and OPDP untitled/warning letters; proactively advise stakeholders.
- Support launch readiness activities.
- Contribute to internal policies, SOPs, guidance documents, and review standards.
- Collaborate to enable timely, compliant material development and approvals.
- Mentor junior regulatory staff or consultants (as applicable).
- Participate in initiatives for process optimization, digital innovation, and operational excellence.
Requirements:
- Bachelor’s degree required (life sciences/pharmacy/regulatory affairs preferred).
- 7+ years in Regulatory Affairs Advertising & Promotion in pharma/biotech.
- Direct experience leading/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 complex therapeutic areas; global promotional regulatory experience; fast-paced/emerging biotech experience.
California pay range: $180,000 USD - $200,000 USD.
Candidates must have current, valid authorization to work in the country where this 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 multiple channels.
- Participate 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/APLB submissions, including timely and accurate FDA 2253 submissions.
- Support review and approval of corporate and external communications (as applicable).
- Monitor and interpret FDA enforcement trends and OPDP untitled/warning letters; proactively advise stakeholders.
- Support launch readiness activities.
- Contribute to internal policies, SOPs, guidance documents, and review standards.
- Collaborate to enable timely, compliant material development and approvals.
- Mentor junior regulatory staff or consultants (as applicable).
- Participate in initiatives for process optimization, digital innovation, and operational excellence.
Requirements:
- Bachelor’s degree required (life sciences/pharmacy/regulatory affairs preferred).
- 7+ years in Regulatory Affairs Advertising & Promotion in pharma/biotech.
- Direct experience leading/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 complex therapeutic areas; global promotional regulatory experience; fast-paced/emerging biotech experience.
California pay range: $180,000 USD - $200,000 USD.
Candidates must have current, valid authorization to work in the country where this role is located.