Director, Regulatory Writing (Biopharma)

Location: Boston, MA, United States; remote work indicated by #LI-Remote

Salary: $220,000–$249,711 USD annually

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead planning and management of regulatory submission documents from preclinical development through registration.
• Author and oversee clinical protocols, Investigator’s Brochures, Development Safety Update Reports, clinical study reports, briefing documents, and IND, CTA, CTR, and NDA summaries.
• Manage external regulatory writing resources and coordinate communication with internal contributors and stakeholders.
• Serve as lead author and document expert for critical regulatory deliverables.
• Represent Regulatory Writing on cross-functional teams with Regulatory Affairs, subject matter experts, and Program Management.
• Develop and improve SOPs, authoring guides, project management tools, and submission-support processes.

Requirements

• BS or MS degree and at least 7 years of progressively responsible regulatory or medical writing experience.
• Demonstrated medical writing experience in pharmaceutical, biotech, or CRO environments, particularly for clinical development documentation.
• Expertise with Microsoft Word and eCTD-compliant formatting requirements.
• Ability to organize and interpret complex scientific and clinical data.
• Strong understanding of ICH, GCP, and FDA standards for regulatory documentation.
• Excellent project management, communication, collaboration, and multi-project execution skills.

Nice to have

• Experience in rare diseases, pediatrics, genetic medicines, or expedited development pathways.
• Experience with Duchenne muscular dystrophy or neuromuscular therapeutic areas.
• Experience working in a growing biotech company while managing external resources.

Culture & Benefits

• Mission-driven environment focused on developing transformative therapies for patients and caregivers.
• Values include humanity, tenacity, creativity, collaboration, curiosity, integrity, and commitment to excellence.
• Comprehensive health, dental, and vision coverage, plus life and disability insurance.
• 401(k) match, paid gender-inclusive parental leave, health and well-being support, education reimbursement, discretionary time off, and commuting benefits.
• Equal opportunity employment with transparent compensation practices.