Director, US Medical Advertising/Promotion Regulatory Review
Takeda
August 13, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Medical Affairs
OBJECTIVES:
- Lead the Promotional Review Team (PRT) process from a US Advertising & Promotion (Ad/Promo) Regulatory perspective for at least one business unit/therapeutic area.
- Lead Ad/Promo Regulatory for assigned business unit/therapeutic area by providing strategic guidance on promotional strategies, campaigns, and materials (feasibility, risk assessment, and compliance with regulatory requirements and internal policies/procedures).
- Collaborate with US Ad/Promo Regulatory Senior Leadership to develop and implement internal policies.
- Provide direct supervision (mentoring, performance management, skills development, staffing) to ensure a unified Ad/Promo Regulatory position for the assigned area.
- Lead and/or negotiate topics with FDA OPDP and/or Advertising and Promotional Labeling Branch (APLB).
- Collaborate with International Regulatory Ad/Promo Review Team leadership on global products/strategies.
ACCOUNTABILITIES:
- Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotion of prescription drugs/biologics.
- Provide regulatory leadership and expert evaluation of critical promotional materials.
- Review clinical evidence to support proposed claims consistent with labeling (with Commercial, Medical, Legal).
- Chair strategic promotional review meetings; support planning/prioritization of promotional and disease state campaigns.
- Provide regulatory strategy guidance to senior Commercial leadership during early project development.
- Support promotional review escalations; act as primary lead during initial PRT and Global Regulatory Affairs elevations.
- Maintain understanding of OPDP/APLB requirements and FDA enforcement trends; represent team on organizational initiatives.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS:
- Degree in life science or equivalent; advanced degree preferred.
- Minimum 7 years regulatory experience in drug/biologics/device; minimum 4 years in Advertising & Promotion regulatory affairs.
- Extensive knowledge of Ad/Promo regulations for HCP, payer, and consumer audiences.
- Experience managing major regulatory submissions/responses and advising development teams.
- Strong oral/written skills, negotiation skills; demonstrated leadership.
- RAC desirable.
TRAVEL:
- Up to ~25% travel (some international may be required).
APPLICATION INSTRUCTIONS:
- Apply via the “Apply” button (employment application process begins; info processed per Takeda Privacy Notice/Terms of Use).
- Lead the Promotional Review Team (PRT) process from a US Advertising & Promotion (Ad/Promo) Regulatory perspective for at least one business unit/therapeutic area.
- Lead Ad/Promo Regulatory for assigned business unit/therapeutic area by providing strategic guidance on promotional strategies, campaigns, and materials (feasibility, risk assessment, and compliance with regulatory requirements and internal policies/procedures).
- Collaborate with US Ad/Promo Regulatory Senior Leadership to develop and implement internal policies.
- Provide direct supervision (mentoring, performance management, skills development, staffing) to ensure a unified Ad/Promo Regulatory position for the assigned area.
- Lead and/or negotiate topics with FDA OPDP and/or Advertising and Promotional Labeling Branch (APLB).
- Collaborate with International Regulatory Ad/Promo Review Team leadership on global products/strategies.
ACCOUNTABILITIES:
- Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotion of prescription drugs/biologics.
- Provide regulatory leadership and expert evaluation of critical promotional materials.
- Review clinical evidence to support proposed claims consistent with labeling (with Commercial, Medical, Legal).
- Chair strategic promotional review meetings; support planning/prioritization of promotional and disease state campaigns.
- Provide regulatory strategy guidance to senior Commercial leadership during early project development.
- Support promotional review escalations; act as primary lead during initial PRT and Global Regulatory Affairs elevations.
- Maintain understanding of OPDP/APLB requirements and FDA enforcement trends; represent team on organizational initiatives.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS:
- Degree in life science or equivalent; advanced degree preferred.
- Minimum 7 years regulatory experience in drug/biologics/device; minimum 4 years in Advertising & Promotion regulatory affairs.
- Extensive knowledge of Ad/Promo regulations for HCP, payer, and consumer audiences.
- Experience managing major regulatory submissions/responses and advising development teams.
- Strong oral/written skills, negotiation skills; demonstrated leadership.
- RAC desirable.
TRAVEL:
- Up to ~25% travel (some international may be required).
APPLICATION INSTRUCTIONS:
- Apply via the “Apply” button (employment application process begins; info processed per Takeda Privacy Notice/Terms of Use).