Remote Senior Manager – US Medical Ad/Promo Regulatory

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. in the United States seeks a Senior Manager, US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations governing promotional materials for prescription drugs and biologics.

You will provide regulatory strategy for complex products, chair promotional review meetings, mentor staff, and partner with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure compliant communications across assigned products.

Qualifications

• Bachelor's Degree in life science or equivalent; advanced degree preferred.
• Minimum 4 years in drug/biologic regulatory affairs; at least 2 years in advertising and promotion.
• Knowledge of regulations for advertising and promotion of pharma/biologic products.
• Experience managing regulatory filings and providing guidance to development teams.

Responsibilities

• Serve as internal expert on FDA regulations and enforcement trends.
• Chair promotional review meetings and advise on promotional materials.
• Provide regulatory guidance to drug development teams for marketing materials.
• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance.
• Present regulatory topics to senior management and cross-functional teams.
• Mentor staff and address resource gaps as needed.
• Liaise with OPDP and APLB reviewers as required.

Skills

FDA regulations

Regulatory leadership

Promotional review

Cross-functional collaboration

Mentoring staff

Risk assessment

Education

Bachelor's in life sciences

Advanced degree preferred

Job description

Takeda Pharmaceutical Co. in the United States seeks a Senior Manager, US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations governing promotional materials for prescription drugs and biologics.

You will provide regulatory strategy for complex products, chair promotional review meetings, mentor staff, and partner with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure compliant communications across assigned products.