Manager, Regulatory CMC (Cell and Gene Therapy)

Location: Hybrid in Somerset, New Jersey, United States

Salary: $127,313–$167,099 USD base pay per year, 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, natural killer cell-based therapies, and other advanced platforms.

What you will do

• Support global CMC regulatory strategies for cell and gene therapy pipeline programs, including CAR-T and lentiviral vector products.
• Plan, prepare, review, and coordinate CMC sections for INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author and maintain CMC regulatory documentation for global development, registration, and commercialization.
• Collaborate with Process Development, Manufacturing, Analytical Development, Quality, and other technical teams.
• Evaluate development reports, validation protocols and reports, comparability assessments, and manufacturing change packages for regulatory impact.
• Support regulatory decision-making and submission strategies across multiple programs and competing priorities.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or a related discipline.
• 5+ years of biotechnology or pharmaceutical industry experience with a strong technical background.
• 1–2 years of Regulatory CMC experience with biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory submissions.
• Experience working with process development, analytical development, or manufacturing teams.
• Familiarity with FDA, EMA, and ICH regulatory requirements.
• Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Nice to have

• Advanced degree such as MS, PhD, or PharmD.
• Experience supporting cell and gene therapies.

Culture & Benefits

• Permanent full-time employment with 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 time, sick time, floating holidays, and company holidays.
• Additional benefits include disability coverage, flexible spending and health savings accounts, family planning resources, well-being initiatives, and commuter benefits.