Sr Manager, Regulatory Affairs CMC (CAR-T)

Location: United States, California, Santa Monica. The role is hybrid, with two remote days and three onsite days. The position will be based in Santa Monica through 2026, with a planned transition to the Thousand Oaks or El Segundo, California office beginning in January 2027.

Salary: $143,225–$185,350 base compensation per year, with potential annual bonus, stock-based incentives, paid time off, and benefits.

Company

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

What you will do

• Support and drive CMC regulatory submissions and lifecycle management for global clinical and commercial cell therapy and CAR-T programs.
• Prepare, coordinate, and review CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions.
• Develop and execute global CMC regulatory strategies aligned with program objectives, timelines, and health authority expectations.
• Assess regulatory risks related to manufacturing changes, vector-related changes, comparability, site expansion, and supply strategies.
• Partner with Technical Operations, MSAT, Process and Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders.
• Support health authority responses, inspection readiness, regulatory meetings, registered-detail maintenance, and continuous improvement initiatives.

Requirements

• Bachelor's degree with eight years of experience, master's degree with six years of experience, or PhD with 0+ years of experience.
• Strong understanding of CMC regulatory requirements for ATMPs and cell therapy products, including global frameworks and regional expectations.
• Experience authoring or coordinating CMC sections of regulatory submissions and supporting lifecycle management activities.
• Ability to interpret regulatory guidance, assess risk, develop practical strategies, and collaborate across technical functions.
• Strong organization, communication, judgment, attention to detail, and ability to manage multiple priorities independently.
• Ability to work onsite three days per week in Santa Monica through 2026 and in Thousand Oaks or El Segundo beginning in January 2027.

Nice to have

• Degree in life sciences, biotechnology, pharmaceutical sciences, chemistry, engineering, or a related scientific field.
• Experience with cell therapy, ATMP, or CAR-T programs across clinical or commercial stages.
• Experience with vector-related regulatory considerations, comparability, complex manufacturing changes, multi-site strategies, or inspection readiness.
• GMP knowledge or experience.

Culture & Benefits

• Flexible hybrid working policy with two remote days and three onsite days.
• Medical, dental, vision, and life insurance plans.
• Paid time off and potential discretionary annual bonus.
• Potential discretionary stock-based long-term incentives, depending on role eligibility.
• Inclusive environment focused on employee development, accountability, collaboration, and talent coaching.