Executive Director, Regulatory Affairs & Promotion — Remote

Dyne Therapeutics; Waltham (MA); On-site; USD 250,000 - 310,000; Full time

Job summary

Dyne Therapeutics seeks an Executive Director of Regulatory Affairs Advertising & Promotion to lead strategy and ensure FDA-aligned messaging across external communications. You will chair PRC and MRC processes, drive compliant promotional campaigns, and partner with launch teams, medical affairs, and legal to balance risk and business goals.

Based in Waltham or remote with travel, you will guide regulatory review, develop guidelines, and mentor teams while maintaining current FDA perspective

Qualifications

• 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 direct 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

Responsibilities

• Lead regulatory strategy and compliance for advertising and promotion across external communications.
• Partner with launch teams, medical affairs, R&D, corporate communications, legal and leadership to align messaging with FDA regulations.
• Chair PRC and MRC reviews, balancing legal requirements with business goals while mitigating risk across campaigns and communications.
• Propose compliant regulatory strategies and solutions to challenging promotional concepts.
• Develop and implement guidelines for creation, review, and submission of external communications content.

Skills

Regulatory reviewer

Regulatory affairs

Promotional compliance

Launch experience

Education

BS degree in scientific, clinical or related area

Advanced degree desirable

Tools

Microsoft Office

Veeva PromoMats

Veeva MedComms

Job description

Dyne Therapeutics seeks an Executive Director of Regulatory Affairs Advertising & Promotion to lead strategy and ensure FDA-aligned messaging across external communications. You will chair PRC and MRC processes, drive compliant promotional campaigns, and partner with launch teams, medical affairs, and legal to balance risk and business goals.

Based in Waltham or remote with travel, you will guide regulatory review, develop guidelines, and mentor teams while maintaining current FDA perspective