Remote US Medical Ad/Promo Regulatory Manager

USA - 3310 Takeda Pharmaceuticals U.S.A., Inc.; Massachusetts; Hybrid; USD 164,000 - 200,000; Full time

Job summary

Takeda is seeking a Manager of US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations governing promotional material for prescription drugs and biologics. The role includes regulatory oversight of at least one product area and collaboration with Regulatory Affairs, Medical, Legal, Commercial and Compliance teams.

The position requires at least 3 years in drug/biologic regulatory affairs, including advertising and promotion, and flexible handling of complex

Qualifications

• Bachelor's degree in life science or equivalent; advanced degree preferred.
• Minimum 3 years in drug/biologic/device regulatory affairs or related field; 1 year in advertising & promotion regulatory affairs.

Responsibilities

• Collaborate across Regulatory Affairs, Medical, Legal, Commercial and Compliance to ensure compliant promotion materials.
• Evaluate promotional materials against FDA regulations and internal standards.
• Assess labeling changes and impact on advertising and promotion.
• Provide regulatory guidance for product labeling during development to enhance marketing.
• Lead or chair promotional review meetings and support process improvements.

Skills

FDA regulations

Regulatory strategy

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in life science or equivalent

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

Tools

Electronic Approval System (EAS)

Regulatory databases

Job description

Takeda is seeking a Manager of US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations governing promotional material for prescription drugs and biologics. The role includes regulatory oversight of at least one product area and collaboration with Regulatory Affairs, Medical, Legal, Commercial and Compliance teams.

The position requires at least 3 years in drug/biologic regulatory affairs, including advertising and promotion, and flexible handling of complex