Global Regulatory Ad Promo Strategy Lead

ALKU; San Diego (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

ALKU is seeking an Associate Director of Regulatory Affairs—Advertising and Promotion (Global) to lead regulatory reviews for US promotional materials and medical communications. The role collaborates with Marketing, Legal, Medical, and other stakeholders to ensure compliance with FDA OPDP, PMR requirements, and company policies.

The ideal candidate will have extensive experience leading US promotional reviews (MLR), oversight of PMR services in other countries, and a record of supporting

Qualifications

• Bachelor’s degree in life sciences or related field.
• 7+ years in Regulatory Affairs Advertising & Promotion.
• Experience leading US prescription drug promotional material reviews.

Responsibilities

• Provide regulatory review and strategic guidance for promotional materials for US prescription drug products across multiple channels.
• Participate as a core member of MLR meetings and provide 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 review and approval of corporate communications as applicable.
• Monitor FDA enforcement trends and provide proactive regulatory guidance.
• Support launch readiness activities.
• Contribute to internal policies, SOPs, and review standards.
• Collaborate across functions to ensure timely and compliant material development.
• Provide mentorship to junior regulatory staff or consultants.

Skills

Regulatory affairs

MLR processes

Excellent communication

Project leadership

Veeva PromoMats

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva PromoMats

Job description

ALKU is seeking an Associate Director of Regulatory Affairs—Advertising and Promotion (Global) to lead regulatory reviews for US promotional materials and medical communications. The role collaborates with Marketing, Legal, Medical, and other stakeholders to ensure compliance with FDA OPDP, PMR requirements, and company policies.

The ideal candidate will have extensive experience leading US promotional reviews (MLR), oversight of PMR services in other countries, and a record of supporting