Manager, Regulatory CMC (Cell and Gene Therapy)

Location: Hybrid role based in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States.

Salary: $127,313–$167,099 USD per year, plus potential performance-based bonus and/or equity.

Company

Global biotechnology company developing cell and gene therapy platforms, including CAR-T, CAR-NK, TCR-T, and other therapies for serious diseases.

What you will do

• Support global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
• Plan, prepare, review, and coordinate CMC sections of INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author and maintain regulatory documentation for global development, registration, and commercialization activities.
• Collaborate with Process Development, Manufacturing, Analytical Development, Quality, and Regulatory CMC stakeholders.
• Evaluate development reports, validation documents, comparability assessments, and manufacturing change packages for regulatory impact and submission strategy.

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 dossier sections.
• Experience with process development, analytical development, or manufacturing teams.
• Familiarity with FDA, EMA, and ICH regulatory requirements.
• Strong technical writing, scientific analysis, project management, communication, and collaboration skills.

Nice to have

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

Culture & Benefits

• Hybrid work arrangement.
• 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 and sick time, floating holidays, and eleven company holidays.
• Additional health, wellness, family care, commuter, and voluntary insurance benefits are available to permanent full-time employees.