Ad Promo Regulatory Lead — US Launch & Compliance

Arrowhead Pharmaceuticals, Inc.; Pasadena (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs, Advertising and Promotion to lead regulatory review of US promotional materials and medical communications.

The role partners with Marketing, Legal and Medical to ensure compliance with FDA-OPDP guidance while enabling commercial objectives. The ideal candidate will have 7+ years in regulatory affairs advertising and promotion, deep knowledge of MLR processes, and experience coordinating cross-functional

Qualifications

• 7+ years of experience in Regulatory Affairs Advertising & Promotion or related field
• Strong knowledge of FDA-OPDP regulations and guidance
• Experience leading US promotional material reviews (MLR)

Responsibilities

• Provide regulatory review and strategic guidance for promotional and medical communications for US prescription drug products across multiple channels
• Participate as core member of MLR meetings and provide risk-based regulatory recommendations
• Advise cross-functional teams on promotional strategy, claims development, substantiation and risk mitigation
• Manage submissions to FDA OPDP and APLB, including FDA 2253 submissions
• Support launch readiness activities and update internal policies and SOPs

Skills

Regulatory affairs

Cross-functional collaboration

Risk-based regulatory guidance

Regulatory strategy

Education

Bachelor’s degree in life sciences/pharmacy/regulatory affairs

Tools

Veeva PromoMats

Job description

Arrowhead Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs, Advertising and Promotion to lead regulatory review of US promotional materials and medical communications.

The role partners with Marketing, Legal and Medical to ensure compliance with FDA-OPDP guidance while enabling commercial objectives. The ideal candidate will have 7+ years in regulatory affairs advertising and promotion, deep knowledge of MLR processes, and experience coordinating cross-functional