Senior Director, Regulatory Affairs CMC (Gene Therapy)

Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected. Office locations: San Diego, California, USA, and Bridgewater, New Jersey, USA.

Salary: $222,000–$303,000 annual.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead CMC regulatory strategy for gene therapy programs from early development through registration and post-approval lifecycle management.
• Prepare and oversee regulatory dossiers, including INDs, CTAs/CTRs, CTNs, IMPD updates, BLA, J-NDA, and MAA submissions.
• Identify CMC regulatory risks and implement mitigation strategies across assigned programs.
• Interpret FDA, EMA, PMDA, and ICH requirements and apply them to development plans and stakeholder decisions.
• Lead complex interactions with health authorities and review manufacturing, analytical, raw material, and facility changes for GMP and ICH compliance.
• Collaborate with global regulatory, technical, scientific, operations, and external partner teams while mentoring junior regulatory professionals.

Requirements

• Bachelor’s degree in a scientific discipline and 10+ years of global CMC Regulatory Affairs or relevant pharmaceutical or biotechnology product development experience.
• 5+ years of gene therapy orphan or rare drug development experience.
• Strong understanding of US, EU, and Japanese biologics and gene therapy regulations, including relevant ICH quality and CMC guidance.
• Experience managing quality aspects of IND, CTA, CTR, IMPD, BLA, J-NDA, and MAA submissions, including eCTD submissions.
• Experience leading health authority interactions and global CMC regulatory strategy on cross-functional development teams.
• Strong communication, collaboration, organization, judgment, and problem-solving skills in a fast-paced environment.

Nice to have

• Master’s degree, PhD, or PharmD.
• RAC certification.
• Experience in neurology, ophthalmology, or post-approval lifecycle management.

Culture & Benefits

• Fully remote work with connection to the hirify.global community and occasional in-person collaboration.
• Medical, dental, vision, and mental health support, plus annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, and service and recognition opportunities.