Senior Manager, US Medical Ad/Promo Regulatory Review
Takeda
September 02, 2026
Remote
United States
$137,000 - $215,270 USD yearly
Corporate Functions
About the role:
- Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Provide regulatory strategic oversight for at least one complex product/therapeutic area or multiple products to ensure promotional material compliance.
Responsibilities/Objectives:
- Understand and interpret complex regulatory requirements and promotional strategy.
- Mentor and develop staff; train and share technical/regulatory guidance.
- Chair promotional review meetings and support Commercial in planning/prioritizing promotional and disease state materials.
- Present regulatory topics to senior management and cross-functional teams.
- Liaison with OPDP and APLB reviewers to request/negotiation advisory comments related to promotional claims.
- Ensure electronic approval system (EAS) review standards are upheld and business needs addressed.
- Track promotional review process effectiveness/efficiency; recommend process improvements.
Position Accountabilities:
- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance; ensure promotional/non-promotional materials follow internal standards.
- Review and assess promotional items for completeness, accuracy, and regulatory compliance.
- Identify regulatory issues; develop strategies and risk mitigation.
- Evaluate regulatory risks and recommend promotional strategy.
- May manage/mentor individuals (performance, staffing) and address resource gaps.
- Collaborate with International Regulatory Ad/Promo review teams for global audiences.
Education/Experience/Skills:
- BS in life science (or equivalent); advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- 4+ years Regulatory Affairs (drug/biologic/device), including 2+ years in Advertising & Promotion; related experience considered.
- Knowledge of advertising/promotion regulations and guidance; experience with major regulatory filings preferred.
- Strong oral/written communication, negotiation, cross-functional collaboration.
- Prior leadership preferred (not required).
Licenses/Certifications:
- RAC desirable (none required).
Travel:
- Up to ~20% travel; some international travel may be required.
Location:
- Remote within the US.
- Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Provide regulatory strategic oversight for at least one complex product/therapeutic area or multiple products to ensure promotional material compliance.
Responsibilities/Objectives:
- Understand and interpret complex regulatory requirements and promotional strategy.
- Mentor and develop staff; train and share technical/regulatory guidance.
- Chair promotional review meetings and support Commercial in planning/prioritizing promotional and disease state materials.
- Present regulatory topics to senior management and cross-functional teams.
- Liaison with OPDP and APLB reviewers to request/negotiation advisory comments related to promotional claims.
- Ensure electronic approval system (EAS) review standards are upheld and business needs addressed.
- Track promotional review process effectiveness/efficiency; recommend process improvements.
Position Accountabilities:
- Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance; ensure promotional/non-promotional materials follow internal standards.
- Review and assess promotional items for completeness, accuracy, and regulatory compliance.
- Identify regulatory issues; develop strategies and risk mitigation.
- Evaluate regulatory risks and recommend promotional strategy.
- May manage/mentor individuals (performance, staffing) and address resource gaps.
- Collaborate with International Regulatory Ad/Promo review teams for global audiences.
Education/Experience/Skills:
- BS in life science (or equivalent); advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- 4+ years Regulatory Affairs (drug/biologic/device), including 2+ years in Advertising & Promotion; related experience considered.
- Knowledge of advertising/promotion regulations and guidance; experience with major regulatory filings preferred.
- Strong oral/written communication, negotiation, cross-functional collaboration.
- Prior leadership preferred (not required).
Licenses/Certifications:
- RAC desirable (none required).
Travel:
- Up to ~20% travel; some international travel may be required.
Location:
- Remote within the US.