Director, Regulatory Affairs (Cell Therapy)

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

Base pay: $168,372–$220,988 USD per year

Company

hirify.global is a global biotechnology company developing cell and gene therapies, including CAR-T, CAR-NK, CAR-γδ T, and other emerging platforms for serious diseases.

What you will do

• Develop and execute global regulatory strategies for pipeline programs.
• Lead submissions of INDs, CTAs, BLAs, MAAs, supplements, variations, and related filings in the United States and other countries.
• Interact with the FDA and other health authorities to obtain feedback and alignment on development strategies.
• Represent Regulatory Affairs on global cross-functional teams and in external collaborations.
• Evaluate the need for in-vitro diagnostic and companion diagnostic development.
• Review promotional materials, improve regulatory processes, provide management updates, and mentor junior team members.

Requirements

• PharmD, PhD, or equivalent degree in a science or healthcare field.
• At least 7 years of regulatory affairs experience in drug development, including IND, CTA, BLA, and MAA filing and approval processes.
• In-depth knowledge of global regulatory requirements, biologics, and cell therapies.
• Experience preparing major regulatory submissions, amendments, and supplements in the United States and other countries.
• Knowledge of companion diagnostic development and strong communication, organizational, leadership, and interpersonal skills.
• Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Nice to have

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

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) 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, sick, floating holiday, and company holiday time.
• Performance-based bonus and/or equity may be available for eligible employees.