Director, Regulatory Affairs (Cell Therapy)

Location: Hybrid role based in Somerset, New Jersey, United States

Salary: $168,372–$220,988 USD base pay annually, plus performance-based bonus and/or equity for eligible roles.

Company

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

What you will do

• Develop and execute global regulatory strategies for pipeline programs.
• Lead IND, CTA, BLA, supplement, variation, and ex-U.S. regulatory submissions.
• Engage 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 needs for pipeline programs.
• Coach junior team members and provide management updates on applications and submissions.

Requirements

• PharmD, PhD, or equivalent degree in a science or healthcare field.
• Broad and in-depth knowledge of global regulatory requirements and drug development.
• Experience preparing major regulatory submissions, amendments, and supplements in the United States and other countries.
• Strong understanding of biologics, cell therapies, and companion diagnostic development.
• Excellent communication, organizational, prioritization, and interpersonal skills.
• English required; applicants must be authorized to work in the United States and complete Form I-9 and E-Verify verification.

Nice to have

• Experience in cell and gene therapy.
• Experience in oncology, immunology, or multiple myeloma drug development.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with company match fully vested on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal, sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family-care resources.