Global Regulatory Affairs Director, Ad Promo

ALKU; Los Angeles (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

ALKU is seeking a Director of Regulatory Affairs, Advertising and Promotion to oversee US promotional materials and advise cross-functional teams across Marketing, Medical, Legal and Market Access from Pasadena or San Diego. The role requires leading US promotional reviews (MLR) and management of PMR vendors in other countries.

The candidate should bring 7+ years in regulatory affairs for prescription drug advertising, strong FDA-OPDP expertise, and experience with Veeva PromoMats or similar

Qualifications

• 7+ years in Regulatory Affairs Advertising & Promotion.
• Experience leading US prescription drug promotional materials.
• Strong working knowledge of FDA-OPDP regulations and MLR processes.
• Familiarity with PMR requirements in other countries.
• Experience with Veeva PromoMats or similar review systems.

Responsibilities

• Provide regulatory review and strategic guidance for promotional and medical communications in the US.
• Lead or participate in MLR meetings and provide risk-based regulatory recommendations.
• Advise cross-functional teams on promotional strategy, claims, fair balance and substantiation.
• Manage submissions to FDA OPDP and APLB, including 2253 submissions for US materials.
• Support review and approval of corporate and external communications.
• Monitor FDA enforcement trends and industry developments to advise stakeholders.
• Contribute to internal policies, SOPs and review standards.
• Mentor junior regulatory staff and consultants.

Skills

Regulatory affairs

Cross-functional collaboration

FDA-OPDP regulations

Education

Bachelor's degree in life sciences or related field

Tools

Veeva PromoMats

Job description

ALKU is seeking a Director of Regulatory Affairs, Advertising and Promotion to oversee US promotional materials and advise cross-functional teams across Marketing, Medical, Legal and Market Access from Pasadena or San Diego. The role requires leading US promotional reviews (MLR) and management of PMR vendors in other countries.

The candidate should bring 7+ years in regulatory affairs for prescription drug advertising, strong FDA-OPDP expertise, and experience with Veeva PromoMats or similar