Executive Director, Regulatory Affairs (Biotechnology)

Location: Onsite in Waltham, Massachusetts, United States

Salary: $270,000–$310,000 USD base pay annually

Company

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

What you will do

• Shape and lead global regulatory strategy for clinical-stage biotechnology programs in alignment with corporate and program objectives.
• Provide strategic oversight of regulatory functions and collaborate with executive stakeholders on enterprise-wide regulatory decisions.
• Lead interactions with FDA, EMA, and other global health authorities, including strategic meetings and regulatory pathway negotiations.
• Oversee major regulatory filings, including INDs, CTAs, NDAs, BLAs, and MAAs, throughout the product lifecycle.
• Direct expedited programs and designations for rare muscle diseases, including Fast Track, Orphan Drug, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy designations.
• Lead inspections, audits, talent development, mentoring, and cross-functional collaboration for product development and launch.

Requirements

• Bachelor’s degree in life sciences or a related discipline; a master’s degree is preferred.
• 18+ years of progressive regulatory affairs experience, including at least 10 years in management or leadership roles.
• Deep regulatory strategy experience in clinical-stage biotechnology and strong knowledge of CTD format and filing content.
• Expertise in FDA, EMA, and international regulations covering clinical, nonclinical, and CMC development.
• Experience leading health authority meetings, negotiating with regulatory agencies, and influencing enterprise-wide decisions.
• Outstanding regulatory writing, communication, strategic thinking, and cross-functional collaboration skills.

Culture & Benefits

• Base compensation is provided within the stated Massachusetts pay range.
• Leadership is expected to model purpose, commitment, vision, resolve, accountability, inclusion, and emotional intelligence.
• The role includes mentoring senior regulatory professionals and developing organizational capability.
• hirify.global is an equal opportunity employer.