Regulatory Ad/Promo Review Lead — Remote

USA - 3310 Takeda Pharmaceuticals U.S.A., Inc.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceuticals U.S.A., Inc. is seeking an Associate Director, US Medical Ad/Promo Regulatory Review as a remote role in Massachusetts.

You will serve as an internal expert on FDA regulations governing the promotion of prescription drug and biologic products, providing regulatory strategic oversight for complex products to ensure compliant promotional materials. You will chair promotional review meetings, interact with OPDP/APLB reviewers, mentor staff, and lead internal Ad/Promo

Qualifications

• Experience in drug/biologic/pDevice regulatory advertising and promotion.

Responsibilities

• Interpret regulatory requirements and promotional strategy for complex products.
• Mentor and develop staff; supervise and train personnel.
• Chair promotional review meetings and coordinate with Commercial on campaigns.
• Liaise with OPDP/APLB reviewers for advisory comments and enforcement letters.
• Present regulatory topics to senior management and cross-functional teams.

Skills

Regulatory strategy

FDA regulations

Promotional review

Leadership

Mentoring

Education

PharmD

PhD

MS

MBA

JD

Tools

Electronic Approval System (EAS)

Regulatory databases

Job description

Takeda Pharmaceuticals U.S.A., Inc. is seeking an Associate Director, US Medical Ad/Promo Regulatory Review as a remote role in Massachusetts.

You will serve as an internal expert on FDA regulations governing the promotion of prescription drug and biologic products, providing regulatory strategic oversight for complex products to ensure compliant promotional materials. You will chair promotional review meetings, interact with OPDP/APLB reviewers, mentor staff, and lead internal Ad/Promo