Director, Regulatory CMC (Cell and Gene Therapy)

Location: Somerset, New Jersey, United States; hybrid

Base pay: $193,629–$254,137 USD annually, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, NK cell-based, and other autologous, allogeneic, and in vivo platforms.

What you will do

• Develop and execute global CMC regulatory strategies for commercial products and development-stage programs.
• Lead regulatory strategy for late-stage development and post-approval lifecycle management.
• Represent Regulatory CMC on cross-functional program teams and governance committees.
• Coordinate regulatory planning, submission preparation, and interactions with health authorities.
• Identify regulatory risks and opportunities and drive mitigation and contingency plans.
• Improve Regulatory CMC processes, best practices, knowledge management, and compliance while supporting junior staff.

Requirements

• Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or a related discipline.
• 10+ years of biotechnology or pharmaceutical industry experience.
• 7+ years of Regulatory CMC experience with biologics, cell therapy, and gene therapy; direct CAR-T experience is desired.
• Strong CMC technical background and ability to evaluate data across scientific disciplines.
• Experience leading late-stage programs and post-approval activities, including lifecycle management, supplements, variations, annual reports, and post-approval commitments.
• Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Nice to have

• Direct experience with CAR-T cell therapies.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal time, sick time, floating holidays, and company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family planning resources, and well-being programs.