Director, US Medical Advertising/Promotion Regulatory Review
Takeda
August 13, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Marketing
Objectives:
- Lead the Promotional Review Team (PRT) from a US Advertising & Promotion (Ad/Promo) Regulatory perspective for at least one business unit/therapeutic area.
- Lead Ad/Promo Regulatory by providing strategic guidance on proposed promotional strategies, campaigns, and materials; evaluate feasibility, risk, and ensure compliance with regulatory requirements and internal policies.
- Collaborate with US Ad/Promo Regulatory senior leadership to develop and implement internal policies.
- Directly supervise team members (mentoring, performance management, skills development, staffing) to ensure a unified regulatory position.
- Lead and/or negotiate with FDA OPDP and/or Advertising and Promotional Labeling Branch (APLB) as needed.
- Collaborate with International Regulatory Ad/Promo Review Team leadership for global products/strategies.
Accountabilities:
- Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotion of prescription drug/biologic products.
- Provide leadership and expert regulatory evaluation of critical promotional materials.
- Review clinical evidence adequacy to support claims consistent with labeling (with Commercial/Medical/Legal).
- Chair strategic promotional review meetings; support planning/prioritization of promotional/disease campaigns.
- Provide early-stage regulatory strategy guidance to senior Commercial leadership.
- Support escalation meetings; act as primary Ad/Promo Regulatory lead during PRT and Global Regulatory Affairs elevations.
- Maintain understanding of OPDP/APLB requirements and FDA enforcement trends; represent initiatives.
- Manage direct reports; uphold consistent review standards in EAS; recommend and implement process improvements.
Education/Experience/Skills:
- Degree in life science or equivalent; advanced degree preferred.
- 7+ years Regulatory Affairs experience (drug/biologic/device), including 4+ years in Advertising & Promotion.
- Extensive knowledge of Ad/Promo regulations/guidance for HCP, payor, and consumer audiences.
- Experience managing major filings/enforcement responses or competitor complaints.
- Strong oral/written communication, negotiation, and cross-functional leadership.
- RAC certification desirable.
Benefits (as stated):
- May include medical/dental/vision insurance, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
- Lead the Promotional Review Team (PRT) from a US Advertising & Promotion (Ad/Promo) Regulatory perspective for at least one business unit/therapeutic area.
- Lead Ad/Promo Regulatory by providing strategic guidance on proposed promotional strategies, campaigns, and materials; evaluate feasibility, risk, and ensure compliance with regulatory requirements and internal policies.
- Collaborate with US Ad/Promo Regulatory senior leadership to develop and implement internal policies.
- Directly supervise team members (mentoring, performance management, skills development, staffing) to ensure a unified regulatory position.
- Lead and/or negotiate with FDA OPDP and/or Advertising and Promotional Labeling Branch (APLB) as needed.
- Collaborate with International Regulatory Ad/Promo Review Team leadership for global products/strategies.
Accountabilities:
- Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotion of prescription drug/biologic products.
- Provide leadership and expert regulatory evaluation of critical promotional materials.
- Review clinical evidence adequacy to support claims consistent with labeling (with Commercial/Medical/Legal).
- Chair strategic promotional review meetings; support planning/prioritization of promotional/disease campaigns.
- Provide early-stage regulatory strategy guidance to senior Commercial leadership.
- Support escalation meetings; act as primary Ad/Promo Regulatory lead during PRT and Global Regulatory Affairs elevations.
- Maintain understanding of OPDP/APLB requirements and FDA enforcement trends; represent initiatives.
- Manage direct reports; uphold consistent review standards in EAS; recommend and implement process improvements.
Education/Experience/Skills:
- Degree in life science or equivalent; advanced degree preferred.
- 7+ years Regulatory Affairs experience (drug/biologic/device), including 4+ years in Advertising & Promotion.
- Extensive knowledge of Ad/Promo regulations/guidance for HCP, payor, and consumer audiences.
- Experience managing major filings/enforcement responses or competitor complaints.
- Strong oral/written communication, negotiation, and cross-functional leadership.
- RAC certification desirable.
Benefits (as stated):
- May include medical/dental/vision insurance, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.