Executive Director, Regulatory Ad & Promo Strategy

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

Job summary

Dyne Therapeutics seeks an Executive Director, Regulatory Affairs Advertising & Promotion to lead regulatory strategy and compliant advertising for all external communications. You will partner with launch teams, medical affairs, R&D, corporate communications, legal and leadership to align messaging with FDA regulations and company objectives.

The role can be located in Waltham or remotely with travel to the office per business needs, requiring strong experience in promotional strategy,

Qualifications

• Minimum 12+ years in pharmaceutical/biotech with 10+ years as primary Regulatory reviewer of advertising and promotion.
• Deep understanding of regulatory advertising and promotion concepts with broad expertise.
• Successful product launches, preferably global.

Responsibilities

• Lead regulatory strategy and compliance for advertising and promotional activities.
• Collaborate with launch teams, medical affairs, R&D, and legal to ensure compliant messaging.
• Chair regulatory reviews for PRC and MRC and manage external communications content.
• Provide guidance on complex promotional claims and regulatory submissions.
• Drive development of guidelines for external communications content.

Skills

Regulatory strategy

FDA regulations

Promotional compliance

Cross-functional leadership

Strategic thinking

Veeva PromoMats

Negotiation

Communication

Education

Bachelor's degree in science

Advanced degree

Tools

Veeva PromoMats

Veeva MedComms

Microsoft Office

Job description

Dyne Therapeutics seeks an Executive Director, Regulatory Affairs Advertising & Promotion to lead regulatory strategy and compliant advertising for all external communications. You will partner with launch teams, medical affairs, R&D, corporate communications, legal and leadership to align messaging with FDA regulations and company objectives.

The role can be located in Waltham or remotely with travel to the office per business needs, requiring strong experience in promotional strategy,