Manager, Regulatory Affairs CMC (CAR-T)

Location: Santa Monica, California, United States through 2026; beginning in January 2027, employees are expected to relocate to the Thousand Oaks, Foster City, or El Segundo, California offices. Hybrid schedule with two remote days and three onsite days per week.

Salary: $133,195–$172,370 per year, plus potential annual bonus, long-term stock incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing CAR and T-cell receptor engineered cell therapies and personalized CAR-T cancer immunotherapies.

What you will do

• Lead operational and lifecycle management activities for global Regulatory CMC submissions, including INDs, IMPDs, BLAs, MAAs, variations, and amendments.
• Act as the Regulatory CMC lead for assigned program and platform teams supporting autologous CAR-T therapies.
• Author, review, and coordinate Module 3 content across the United States, European Union, and other international regions.
• Develop CMC regulatory strategies for site additions, process and raw-material changes, analytical updates, and shelf-life extensions.
• Identify regulatory risks, anticipate health-authority questions, and develop mitigation and contingency plans.
• Collaborate with Technical Operations, Quality, Process Development, Analytical, Manufacturing, and Global Regulatory Affairs teams on submissions and regulatory interactions.

Requirements

• Bachelor’s degree with six years of experience, or master’s degree with four years of experience.
• At least five years of relevant Regulatory CMC or drug development experience, including work with FDA-regulated products.
• Experience with global regulatory requirements, including FDA, EMA, and other international agencies.
• Strong written and verbal communication skills, organization, independent judgment, and cross-functional collaboration abilities.
• Ability to work in the hybrid California office schedule and account for the planned relocation to another California office in January 2027.

Nice to have

• Degree in chemistry, biochemistry, biology, chemical engineering, or a related scientific discipline.
• Experience with biologics, cell or gene therapy products, autologous CAR-T therapies, or advanced therapy medicinal products.
• Experience supporting both clinical development and commercial lifecycle management.

Culture & Benefits

• Fast-paced, collaborative biotechnology environment with high expectations for initiative and independent judgment.
• Flexible hybrid working policy with two remote days and three onsite days each week.
• Medical, dental, vision, and life insurance plans.
• Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
• Focus on inclusion, talent development, team empowerment, and ethical conduct.