Executive Director, Regulatory Affairs Advertising & Promotion

Executive Director, Regulatory Affairs Advertising & Promotion

Company Overview

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

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 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.

Location – Waltham, MA (suitable for on-site work only).

Primary Responsibilities

• Serve 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 identify and evaluate fundamental issues, providing strategy and direction, anticipating factors that could influence strategies and company position in the market.
• Lead the PRC to navigate complicated claims while juggling requirements of laws and regulations, interpreting and implementing FDA Guidance.
• Serve 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.
• Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk.
• Support 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.
• Provide promotional regulatory input on concepts and draft materials to ensure alignment with promotional regulations, corporate standards and policies and business objectives.
• Lead the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission of external communications content.
• Act as the recognized authority on regulatory advertising and promotion matters, able to work independently and collaborate with internal or external agencies.
• Serve as primary Regulatory Advertising & Promotion contact for Regulatory Agencies.
• Actively participate in labeling and global regulatory team meetings to support anticipated promotional messages and claims in clinical trial design and product labeling.
• Maintain current awareness of evolving FDA regulations and communications, and communicate significant changes to relevant stakeholders.
• Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.

Education and Skills Requirements

• BS degree in a scientific, clinical or related area required; advanced degree highly desirable.
• 12+ years pharmaceutical/biotech industry experience with a minimum of 10 years as a primary Regulatory reviewer of advertising and promotional materials.
• In-depth understanding of strategic regulatory advertising and promotion concepts and breadth of regulatory expertise.
• Successfu…