Senior Director, CMC Regulatory Affairs – Hybrid

Allogene Therapeutics; United States; Hybrid; USD 230,000 - 270,000; Full time

Benefits offered by this job

Bonus

Equity

Health insurance

Paid time off

Job summary

Allogene Therapeutics, a South San Francisco, CA-based biotech company, is seeking a Senior Director, CMC Regulatory Affairs to lead global regulatory strategy for CAR T programs. This hybrid role reports to the Head of Regulatory Affairs and guides quality, manufacturing, and supply chain teams to ensure compliant CMC submissions.

The role requires extensive GMP/ICH knowledge, experience with INDs/CTAs/BLAs/MAAs, and strong leadership in interactions with US, EU, and Japan regulators.

Qualifications

• Advanced scientific degree in sciences or health-related field.
• CMC regulatory experience in pharma/biotech.
• Experience filing regulatory submissions from development to post-approval in cell therapy.
• Knowledge of GMP, ICH, FDA/EMA guidelines.
• Experience with health authority inspections desirable.
• Prior supervisory experience preferred.
• Strong regulatory writing and communication skills.
• Authorized to work in the U.S.

Responsibilities

• Provide strategic CMC regulatory leadership for multiple Allogeneic CAR T programs.
• Provide CMC regulatory support for global development and registration programs (INDs, CTAs, BLAs, MAAs).
• Primary regulatory representative at meetings with regulatory agencies for CMC issues.
• Lead negotiations with regulatory agencies and manage global interactions for INDs/CTAs and registrations.
• Ensure regulatory compliance and manage reporting timelines.
• Prepare CMC sections of INDs/CTAs and responses with internal SMEs.
• Support quality systems and inspections related to CMC.
• Manage contract staff and vendors for regulatory activities.
• Other duties as assigned.

Skills

CMC regulatory leadership

Regulatory submissions

GMP knowledge

eCTD writing

Cross-functional collaboration

Education

Advanced scientific degree

Job description

Allogene Therapeutics, a South San Francisco, CA-based biotech company, is seeking a Senior Director, CMC Regulatory Affairs to lead global regulatory strategy for CAR T programs. This hybrid role reports to the Head of Regulatory Affairs and guides quality, manufacturing, and supply chain teams to ensure compliant CMC submissions.

The role requires extensive GMP/ICH knowledge, experience with INDs/CTAs/BLAs/MAAs, and strong leadership in interactions with US, EU, and Japan regulators.