Executive Director, Regulatory Affairs Advertising & Promotion

Benefits

Additional Information

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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook . 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 s ubject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives Proactively i dentifies and evaluates fundamental issues, providing strategy and direction , a nticipat ing factors that could influence strategies and company position in the market Lead s the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance S erves 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 lau n ch teams , participating in strategy discussions and extended team meetings to provid e 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 p rimary Regulatory Advertising & Promotion contact for Regulatory Agencies Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion. Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry and C ommunicates significant changes in FDA perspective to relevant stakeholders. Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review Education and Skills Requirements: BS degree in scientific, clinical or related area required . Advanced degree highly desirable. 12+ years pharmaceutical/biotech industry experience with a minimum of 10 years of d irect experience as primary Regulatory reviewer of advertising and promotional materials is required In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising & promotion expertise Successful launch experience, preferably including global product launches Works comfortably with abstract ideas or situations across functional areas of the business Strong track record of implementing suc

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at dynetherapeutics? Share your experience