Executive Director, Regulatory Affairs Advertising & Promotion (Biotech)

Location: Waltham, Massachusetts, or remote within the United States, with travel to the office as needed

Salary: $250,000–$310,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to improve function for people living with genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead regulatory strategy and compliance for advertising, promotional activities, scientific exchange, and corporate communications.
• Chair the Promotion Review Committee and serve as the Regulatory Advertising & Promotion lead for the Medical Review Committee.
• Review and approve external communications, promotional materials, corporate messaging, and complex promotional claims.
• Provide regulatory guidance to commercial launch teams and cross-functional partners across commercial, medical affairs, R&D, legal, communications, and leadership.
• Develop guidelines and processes for content creation, regulatory review, approval, and submission.
• Monitor evolving FDA regulations, guidance, advisory letters, and enforcement actions, and communicate relevant changes to stakeholders.

Requirements

• BS degree in a scientific, clinical, or related area; an advanced degree is highly desirable.
• 12+ years of pharmaceutical or biotech industry experience, including at least 10 years as the primary regulatory reviewer of advertising and promotional materials.
• In-depth expertise in strategic regulatory advertising and promotion, FDA guidance, promotional claims, and compliant campaign development.
• Successful product launch experience, preferably including global launches and regulatory strategy for product filings or launches.
• Demonstrated experience interacting with FDA promotional review divisions, including OPDP or APLB.
• Strong communication, negotiation, influencing, technical writing, analytical, and problem-solving skills, with proficiency in Microsoft Office, Veeva PromoMats, and Veeva MedComms.

Culture & Benefits

• Work in a cross-functional environment spanning commercial, medical, R&D, legal, corporate communications, and leadership.
• Opportunity to support innovative regulatory strategies for branded and unbranded promotional campaigns.
• Role aligned with Dyne’s mission to improve function for individuals and families affected by neuromuscular diseases.