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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. 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 successful business strategies for branded and unbranded promotional campaigns  

Ability to see impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities.  

Strong interpersonal skills  and  p roven negotiator  with   demonstrated  ability to use constructive debate to  identify  and move others towards compliant promotional outcomes  

Ability to communicate and influence without authority at all levels of the organization and externally  

Well organized with exceptional communication skills, strong influencing skills, strong technical  writing  and documentation skills, as well as strong analytical and problem-solving skills  

Thinks innovatively and creatively,  identifying  the risks surrounding promotional claims and campaigns   

Proficient in computer applications and configurations including Microsoft Office Suite or related software, Veeva  PromoMats  and Veeva  MedComms  systems  

Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch  

Positive team member who  embodies the Dyne Core Values  

Excitement about Dyne’s vision and mission   

MA Pay Range

$250,000 — $310,000 USD

 

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.