Remote US Medical Ad/Promo Regulatory Manager

Regulatory Jobs; Massachusetts; Hybrid; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Manager, US Medical Ad/Promo Regulatory Review to act as an internal expert on FDA regulations and enforcement trends governing the promotion of prescription drugs and biologics. You will provide regulatory strategy for complex products and ensure promotional materials comply with FDA guidance.

The role requires collaboration across Regulatory Affairs, Medical, Legal, Commercial and Compliance, evaluating materials, guiding labeling discussions, and potentially chairing

Qualifications

• Bachelor's Degree in life science or equivalent; Advanced degree preferred.
• Minimum 3 years' experience in drug, biologic or device Regulatory Affairs; at least 1 year in Advertising and Promotion.
• Knowledge of FDA regulations.
• Ability to provide regulatory guidance merging scientific principles and FDA law.
• Knowledge of historical enforcement actions helpful for recommendations to stakeholders.
• Excellent oral and written skills; strong cross-functional collaboration.

Responsibilities

• Collaborate with Regulatory Affairs, Medical, Legal, Commercial and Compliance to ensure materials align with internal processes and standards.
• Researches and evaluates advertisement and promotional precedents to provide clear guidance.
• Evaluates materials for FDA regulatory compliance and corporate standards.
• Assesses labeling changes impact on advertising and promotional materials.
• May chair promotional review meetings and assist with planning promotional materials.
• Interprets scientific data for regulatory requirements and strategy for claims.
• Identifies regulatory issues and proposes solutions, showing increasing independence.
• Ensures consistency in the electronic approval system and supports process improvements.

Skills

FDA regulations

Regulatory guidance

Cross-functional collaboration

Oral and written communication

Project leadership

Problem solving

Education

Bachelor's in life science

Advanced degree preferred

Job description

Takeda is seeking a Manager, US Medical Ad/Promo Regulatory Review to act as an internal expert on FDA regulations and enforcement trends governing the promotion of prescription drugs and biologics. You will provide regulatory strategy for complex products and ensure promotional materials comply with FDA guidance.

The role requires collaboration across Regulatory Affairs, Medical, Legal, Commercial and Compliance, evaluating materials, guiding labeling discussions, and potentially chairing