Regulatory Ads & Promo Strategy Lead (Remote)

Takeda Pharmaceutical Co.; Agawam (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking an Associate Director for US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations, guiding strategic oversight of promotional materials for complex products.

This remote US role reports to the Director and emphasizes cross-functional leadership, risk mitigation, and policy-aligned communications. The candidate will mentor staff, chair review meetings, and interact with OPDP/APLB reviewers to ensure compliant claims and

Qualifications

• Minimum of a life science degree; advanced degree preferred.
• 5+ years in drug, biologic or device regulatory affairs, including 3+ years in advertising and promotion.
• Extensive knowledge of regulations and guidance for advertising and promotion of pharmaceutical/biologic products.
• Experience leading regulatory review for marketing materials and interactions with regulatory agencies.

Responsibilities

• Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotional materials.
• Chair promotional review meetings and liaise with OPDP/APLB reviewers.
• Provide regulatory guidance to product development teams and cross-functional partners.
• Lead internal Ad/Promo project workstreams and present findings to senior management.
• Collaborate with international regulatory teams for global materials.

Skills

FDA regulations knowledge

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory submissions

Education

Life science degree

Advanced degree preferred (PharmD/PhD/MS/MBA/JD)

Job description

Takeda Pharmaceutical Co. is seeking an Associate Director for US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations, guiding strategic oversight of promotional materials for complex products.

This remote US role reports to the Director and emphasizes cross-functional leadership, risk mitigation, and policy-aligned communications. The candidate will mentor staff, chair review meetings, and interact with OPDP/APLB reviewers to ensure compliant claims and