Executive Director, Regulatory Affairs Advertising & Promotion
BioSpace, Waltham, MA, United States
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We develop 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), myotonic dystrophy type 1 (DM1), 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. 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. The 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. The position is based in Waltham, MA and is not fully remote.
Primary Responsibilities
Serve as the subject‑matter expert for Regulatory Affairs Ad/Promo, providing leadership and developing innovative and compliant strategies to support communication and promotional objectives.
Proactively identify and evaluate fundamental issues, providing strategy and direction while anticipating factors that could influence strategies and the company’s position in the market.
Lead the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance.
Act as the lead Regulatory Advertising & Promotion expert on the MRC.
Be accountable for the review and approval of external communications materials for promotion, scientific exchange, and corporate messaging, ensuring relevance to corporate goals and deliverables with broad organizational impact. Delegate tasks effectively when needed.
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, policies, and business objectives.
Lead the development and implementation of guidelines and processes for the creation, review, approval, and regulatory submission (where applicable) of external communications content.
Act as the recognized authority on regulatory advertising and promotion matters, working independently and interacting with division or corporate functions, as well as external agencies.
Serve as the primary 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 in clinical trial design and product labeling related to the use of study results in U.S. and global promotion.
Maintain current awareness of evolving FDA regulations and interpretations, advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry, and communicate significant changes in FDA perspective 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 in the pharmaceutical/biotech industry with a minimum of 10 years of direct experience as a primary regulatory reviewer of advertising and promotional materials.
In‑depth understanding of strategic regulatory advertising and promotion concepts and breadth of regulatory advertising & promotion expertise.
Successful launch experience, preferably including global product launches.
Comfortable working 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 the impact of decisions across various organization segments, including Medical Affairs and Corporate Communications.
Strong interpersonal skills and proven negotiation ability with constructive debate to identify and move others toward compliant promotional outcomes.
Ability to communicate and influence without authority at all organization levels and externally.
Well organized with exceptional communication skills, strong influencing skills, technical writing and documentation skills, and strong analytical and problem‑solving skills.
Innovative and creative thinker, identifying the risks surrounding promotional claims and campaigns.
Proficient in Microsoft Office Suite, Veeva PromoMats, and Veeva MedComms systems.
Demonstrated history of successful interactions with FDA promotional review divisions (OPDP/APLB) or experience developing/leading regulatory strategy for a product filing/launch.
Positive team member embodying the Dyne Core Values.
Excitement about Dyne’s vision and mission.
Pay Range MA Pay Range: $250,000 - $305,000 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. These statements describe general principles and are not an all‑inclusive listing of duties. Individuals may perform additional duties as assigned.
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.
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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. The 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. The position is based in Waltham, MA and is not fully remote.
Primary Responsibilities
Serve as the subject‑matter expert for Regulatory Affairs Ad/Promo, providing leadership and developing innovative and compliant strategies to support communication and promotional objectives.
Proactively identify and evaluate fundamental issues, providing strategy and direction while anticipating factors that could influence strategies and the company’s position in the market.
Lead the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance.
Act as the lead Regulatory Advertising & Promotion expert on the MRC.
Be accountable for the review and approval of external communications materials for promotion, scientific exchange, and corporate messaging, ensuring relevance to corporate goals and deliverables with broad organizational impact. Delegate tasks effectively when needed.
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, policies, and business objectives.
Lead the development and implementation of guidelines and processes for the creation, review, approval, and regulatory submission (where applicable) of external communications content.
Act as the recognized authority on regulatory advertising and promotion matters, working independently and interacting with division or corporate functions, as well as external agencies.
Serve as the primary 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 in clinical trial design and product labeling related to the use of study results in U.S. and global promotion.
Maintain current awareness of evolving FDA regulations and interpretations, advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry, and communicate significant changes in FDA perspective 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 in the pharmaceutical/biotech industry with a minimum of 10 years of direct experience as a primary regulatory reviewer of advertising and promotional materials.
In‑depth understanding of strategic regulatory advertising and promotion concepts and breadth of regulatory advertising & promotion expertise.
Successful launch experience, preferably including global product launches.
Comfortable working 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 the impact of decisions across various organization segments, including Medical Affairs and Corporate Communications.
Strong interpersonal skills and proven negotiation ability with constructive debate to identify and move others toward compliant promotional outcomes.
Ability to communicate and influence without authority at all organization levels and externally.
Well organized with exceptional communication skills, strong influencing skills, technical writing and documentation skills, and strong analytical and problem‑solving skills.
Innovative and creative thinker, identifying the risks surrounding promotional claims and campaigns.
Proficient in Microsoft Office Suite, Veeva PromoMats, and Veeva MedComms systems.
Demonstrated history of successful interactions with FDA promotional review divisions (OPDP/APLB) or experience developing/leading regulatory strategy for a product filing/launch.
Positive team member embodying the Dyne Core Values.
Excitement about Dyne’s vision and mission.
Pay Range MA Pay Range: $250,000 - $305,000 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. These statements describe general principles and are not an all‑inclusive listing of duties. Individuals may perform additional duties as assigned.
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.
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