Associate Director, Ad Promo Regulatory

Adweek; Pasadena (CA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Excellent benefits

Zusammenfassung

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA, seeks an Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) to lead U.S. promotional material review and provide regulatory guidance across channels and programs.

The role requires 7+ years in RA-Advertising & Promotion, strong FDA-OPDP knowledge, PMR experience, and ability to partner with Marketing, Medical, Legal, and others. Launch support and global awareness are a plus.

Qualifikationen

• 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

Aufgaben

• 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, and risk-based regulatory recommendations.
• Confidently advise cross-functional teams on promotional strategy, claims development, fair balance, substantiation requirements, and risk mitigation.
• Manage all submissions to FDA OPDP and APLB, including timely and accurate FDA 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 the 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.

Kenntnisse

Regulatory Affairs

US promotional review

Cross-functional collaboration

Mentorship

Regulatory strategy

Ausbildung

Bachelor’s degree

Tools

Veeva PromoMats

Jobbeschreibung

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA, seeks an Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) to lead U.S. promotional material review and provide regulatory guidance across channels and programs.

The role requires 7+ years in RA-Advertising & Promotion, strong FDA-OPDP knowledge, PMR experience, and ability to partner with Marketing, Medical, Legal, and others. Launch support and global awareness are a plus.