Associate Director, Regulatory Affairs (Cell Therapy)

Location: Hybrid role based in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Base pay: $168,372–$220,988 USD per year, plus potential performance-based bonus and/or equity.

Company

hirify.global is a biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, and natural killer cell-based therapies for serious diseases.

What you will do

• Develop, coordinate, and execute global regulatory strategies for pipeline programs.
• Lead preparation and submission of INDs, CTAs, BLAs, amendments, supplements, and ex-US filings.
• Interact with the FDA and other health authorities on preclinical and clinical development strategies.
• Represent Regulatory Affairs on global cross-functional teams and external collaborations.
• Evaluate in-vitro diagnostic and companion diagnostic requirements for pipeline programs.
• Coach junior regulatory professionals and provide management with updates on applications and submissions.

Requirements

• PharmD, PhD, or equivalent degree in a science or healthcare field.
• At least 5 years of regulatory affairs experience in drug development, including IND, CTA, BLA, or MAA filing and approval processes.
• Broad knowledge of global drug development regulations and experience preparing major US and ex-US submissions.
• Experience with biologics and cell therapies, with knowledge of companion diagnostic development.
• Excellent communication, organizational, prioritization, and interpersonal skills.
• English proficiency and authorization to work in the United States are required.

Nice to have

• Experience in cell and gene therapy.
• Experience in drug development for multiple myeloma.
• Understanding of the regulatory landscape in oncology, immunology, and cell therapy.

Culture & Benefits

• Hybrid work environment within a global biotechnology organization.
• Medical, dental, and vision insurance.
• 401(k) plan with company matching that vests fully on the first day.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal, sick time, floating holidays, and company holidays.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.