Executive Director, Regulatory Affairs (Biotechnology)

Location: Waltham, Massachusetts, United States; onsite

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

Company

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

What you will do

• Shape and lead global regulatory strategy for clinical and preclinical biotechnology programs.
• Provide strategic oversight of regulatory activities through functional managers and leaders.
• Lead interactions with the FDA, EMA, and other global health authorities, including critical strategic meetings.
• Oversee preparation and submission of INDs, CTAs, NDAs, BLAs, and MAAs.
• Direct strategies for expedited programs and designations, including Fast Track, Orphan Drug, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy.
• Lead regulatory inspections and audits, monitor regulatory trends, and guide cross-functional product development and launch activities.

Requirements

• Bachelor's degree in life sciences or a related discipline required; master's degree preferred.
• 18+ years of progressive regulatory affairs experience, including at least 10 years in management or leadership roles.
• Deep regulatory strategy expertise in clinical-stage biotechnology and strong knowledge of CTD format and filing content.
• Knowledge of FDA, EMA, and international requirements for 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

• Leadership culture centered on purpose, commitment, vision, resolve, accountability, and inclusion.
• Opportunity to mentor senior regulatory professionals and build long-term organizational capability.
• Role with broad decision-making authority across regulatory operations and enterprise strategy.
• Equal opportunity employment.