US Medical Ad/Promo Regulatory Lead

USA - 3310 Takeda Pharmaceuticals U.S.A., Inc.; Massachusetts; Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Manager, US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations, guiding promotional materials for US products. This role collaborates across Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure compliant development and reviews.

The position emphasizes leadership, mentoring staff, and presenting regulatory topics to senior management, with up to 20% travel and remote work within the US.

Qualifications

• Bachelor's degree in life science or equivalent.
• Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including at least 2 years in Regulatory Affairs – Advertising and Promotion.

Responsibilities

• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure compliant promotional materials.
• Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing promotion of prescription drug/biologic products.
• Review proposed promotional items for completeness, accuracy, and regulatory compliance.
• Provide regulatory guidance to development teams merging science and FDA law.
• Lead mentoring and development of staff and potential oversight of resources.

Skills

Regulatory expertise

Communication skills

Leadership potential

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in life science

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

Job description

Takeda is seeking a Senior Manager, US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations, guiding promotional materials for US products. This role collaborates across Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure compliant development and reviews.

The position emphasizes leadership, mentoring staff, and presenting regulatory topics to senior management, with up to 20% travel and remote work within the US.