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

About the role

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on diseases with a genetic basis, typically characterized by overproduction of proteins involved in disease, and is leading the field in bringing RNAi therapies beyond the liver with clinical programs in liver and lung plus a promising preclinical pipeline. Corporate headquarters are in Pasadena, CA, with R&D teams in Madison, WI and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI.

The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) is a strategic role partnering cross-functionally with Marketing, Medical, Legal, Market Access, Corporate Communications, and other stakeholders to ensure promotional materials comply with country and local regulations, industry standards, and company policies while supporting business objectives. The ideal candidate is a collaborative, solutions-oriented regulatory professional with strong communication and organizational skills who can balance regulatory risk with commercial innovation. Experience leading or facilitating US promotional review committees (MLR) and overseeing vendors providing promotional material review (PMR) services in other countries is required; product launch experience is preferred.

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.
• Participate as a core member of MLR meetings and provide clear, practical, risk-based regulatory recommendations.
• 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 timely and accurate FDA Form 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 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.
• Candidates must have current, valid authorization to work in the United States.

Preferred qualifications

• 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 – $240,000 USD annually. Arrowhead provides competitive salaries and an excellent benefit package.