Executive Director, Regulatory Affairs Advertising & Promotion

Role Summary:

The Executive Director, Regulatory Affairs Advertising & Promotion leads regulatory strategy and compliance for advertising and promotional activities across all external communications. This role serves as the subject matter expert, partnering with the launch team, commercial, medical affairs, R&D, corporate communications, legal, and leadership to ensure messaging aligns with FDA regulations and company objectives. The person in this role provides strategic guidance on complex promotional claims, anticipates market and regulatory factors, and drives innovative, compliant solutions. This role chairs the regulatory review for the Promotion Review Committee (PRC) and for the Medical Review Committee (MRC), balancing legal requirements with business goals while mitigating risk across promotional campaigns and corporate communications. 

This role can be located in Waltham or remotely with travel to our office per business needs.

Primary Responsibilities Include: 

• Serves as the subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives 
• Proactively identifies and evaluates fundamental issues, providing strategy and direction, anticipating factors that could influence strategies and company position in the market 
• Leads the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance 
• Serves as lead Regulatory Advertising & Promotion expert on MRC 
• Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution 
• Proposes creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk 
• Supports Commercial launch teams, participating in strategy discussions and extended team meetings to provide regulatory guidance and perspective on marketing strategies and promotion objectives and tactics 
• Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives 
• Leads the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission, where applicable, of external communications content 
• Acts as the recognized authority on regulatory advertising and promotion matters. Able to work independently and deal with division or corporate functions, or with external agencies. 
• Serves as primary Re