Remote US Medical Ad/Promo Regulatory Manager

Takeda Pharmaceutical Company Limited; Adams (MA); Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking a Manager, US Medical Ad/Promo Regulatory Review to act as an internal expert on FDA regulations governing prescription drug and biologic product promotion. You will oversee regulatory guidance for complex products and ensure promotional materials meet FDA, global codes, and internal standards.

The role involves collaboration across Regulatory Affairs, Medical, Legal, and Commercial teams, evaluating materials for compliance, and providing

Qualifications

• Bachelor's degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum 3 years' experience in drug, biologic or device Regulatory Affairs or related field, including at least 1 year in Regulatory Affairs - Advertising and Promotion.
• Knowledge of FDA regulations and ability to provide regulatory guidance merging scientific principles and FDA law for marketing materials.
• Ability to handle regulatory issues with limited guidance and provide strategic advice to development teams.
• Strong understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Maintain current knowledge of applicable government regulations, particularly advertising and promotion, and global codes of practice.

Responsibilities

• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to ensure promotional material development follows internal processes and standards.
• Research and evaluate advertisement and promotional precedents to provide clear guidance to stakeholders.
• Evaluate materials for compliance with FDA regulations, corporate standards and business objectives.
• Assess impact of labeling changes on advertising and promotional materials.
• Chair promotional review meetings and assist with planning and prioritization of materials.
• Interpret scientific data in relation to regulatory requirements and strategy for claims.
• Identify regulatory issues and propose creative risk-mitigating solutions.

Skills

Regulatory knowledge

Regulatory guidance

Cross-functional teamwork

Problem solving

Oral and written communication

Education

Bachelor's degree in life science

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

Job description

Takeda Pharmaceutical Company Limited is seeking a Manager, US Medical Ad/Promo Regulatory Review to act as an internal expert on FDA regulations governing prescription drug and biologic product promotion. You will oversee regulatory guidance for complex products and ensure promotional materials meet FDA, global codes, and internal standards.

The role involves collaboration across Regulatory Affairs, Medical, Legal, and Commercial teams, evaluating materials for compliance, and providing