Senior Ad/Promo Regulatory Lead — Remote

Takeda Pharmaceutical Co.; Boston (MA); À distance; USD 154 000 - 243 000; Plein temps

Résumé du poste

Takeda seeks an Associate Director, US Medical Ad/Promo Regulatory Review, to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will provide regulatory strategic oversight for at least one complex product or therapeutic area and report to the Director, US Medical Ad/Promo Regulatory.

This is a remote role within the US.

Qualifications

• Requires degree in life sciences or equivalent; advanced degree preferred.
• Minimum of 5 years’ experience in drug/biologic/device regulatory affairs; at least 3 years in advertising & promotion.
• Extensive knowledge of regulations and guidance for pharma/biologic advertising and promotion.
• Experience leading regulatory guidance, strategy, and risk mitigation in cross-functional teams.

Responsabilités

• Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotion of prescription drugs and biologics.
• Chair promotional review meetings and guide prioritization of materials.
• Act as primary liaison with OPDP/APLB reviewers for advisory comments and discussions.
• Develop product development and label strategies to support promotional claims.
• Lead Ad/Promo project workstreams and present findings to senior management and cross-functional teams.

Connaissances

Regulatory affairs

Leadership

Regulatory strategy

Cross-functional collaboration

Mentoring

Formation

Life sciences degree

Advanced degree preferred

Description du poste

Takeda seeks an Associate Director, US Medical Ad/Promo Regulatory Review, to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will provide regulatory strategic oversight for at least one complex product or therapeutic area and report to the Director, US Medical Ad/Promo Regulatory.

This is a remote role within the US.