Associate Director, Global Regulatory Labeling and Ad Promo

What You’ll Do:

The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling
• Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements
• Support labeling negotiations with FDA and manage implementation of approved labeling updates
• Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
• Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner
• Ensure compliance with FDA regulations, including:
  • FD&C Act requirements
  • FDA advertising and promotion regulations
  • OPDP guidance and enforcement trends
  • PhRMA Code requirements
  • Company policies and procedures
• Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
• Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review
• Contribute to the development and maintenance of SOPs, policies, and governance processes

Required Qualifications:

• Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
• Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
• Demonstrated deep knowledge of the integrated drug development process
• Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Strong written, spoken and presentation communication
• Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
• Travel expected (10-15%)

Education:

• Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience