Global Regulatory Advertising & Promotion Director

ALKU; San Diego (CA); Presencial; USD 200.000 - 320.000; Jornada completa

Descripción de la vacante

ALKU is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead regulatory reviews for US promotional materials across channels such as digital, print, and events. The role partners with Marketing, Legal, Medical, and Communications to balance risk with commercial goals.

The ideal candidate has extensive experience in US promotional review, FDA OPDP regulations, and global PMR processes, with a track record of guiding teams and launching products.

Formación

• Bachelor's degree required; life sciences, pharmacy, regulatory affairs or related field preferred.
• 7+ years of Regulatory Affairs Advertising & Promotion experience in pharma/biotech.
• Direct experience leading or reviewing US prescription drug promotional materials.
• Strong working knowledge of FDA-OPDP regulations governing pharmaceutical advertising and promotion; MLR processes.
• Working knowledge of PMR requirements in other countries.
• Familiarity with Veeva PromoMats or similar review systems.

Responsabilidades

• Provide regulatory review and strategic guidance for promotional and medical communications for US prescription drugs across multiple channels.
• Participate as a 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 FDA submissions to OPDP and APLB, including FDA 2253 submissions for US materials.
• Support review and approval of corporate and external communications.
• Monitor FDA enforcement trends and industry developments to advise stakeholders.
• Support launch readiness activities and contribute to SOPs and review standards.
• Collaborate across functions to ensure timely and compliant material development and approvals.
• Mentor junior regulatory staff or consultants as applicable.
• Participate in cross-functional initiatives related to process optimization and digital innovation.

Conocimientos

Regulatory affairs

FDA regulations

Regulatory strategy

Cross-functional leadership

Risk assessment

Educación

Bachelor's degree in life sciences or related

Herramientas

Veeva PromoMats

Descripción del empleo

ALKU is seeking a Director of Regulatory Affairs, Advertising and Promotion to lead regulatory reviews for US promotional materials across channels such as digital, print, and events. The role partners with Marketing, Legal, Medical, and Communications to balance risk with commercial goals.

The ideal candidate has extensive experience in US promotional review, FDA OPDP regulations, and global PMR processes, with a track record of guiding teams and launching products.