CMC Regulatory Affairs Manager, Cell Therapy & LVV

Kite Pharma, Inc.; Parsippany-Troy Hills (NJ); Hybrid; USD 133,000 - 190,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based long-term incentives

Paid time off

Benefits package

Job summary

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to drive regulatory submissions and lifecycle management for LVV and cell therapy products. The role requires coordinating cross-functional teams and guiding global CMC strategies.

The position supports a hybrid work model with relocation considerations to CA/NJ as needed. Relocation to Thousand Oaks, El Segundo, Foster City, or Parsippany is anticipated in 2027.

Qualifications

• Bachelor’s degree with Six Years' experience.
• Master’s degree with Four Years' experience.
• Degree in a scientific discipline is preferred.

Responsibilities

• Prepare and submit CMC regulatory filings (INDs, CTAs, BLAs, MAAs, variations).
• Develop global CMC regulatory strategies for LVV and cell therapy products.
• Collaborate with Process Design, MSAT, Quality, Manufacturing, and Supply Chain on regulatory deliverables.
• Support health authority interactions and responses to information requests.

Skills

CMC regulatory

Regulatory submissions

Cell & gene therapy

LVV (lentiviral vectors)

Health authority interactions

Education

Bachelor’s degree

Master’s degree

Scientific discipline degree

Job description

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to drive regulatory submissions and lifecycle management for LVV and cell therapy products. The role requires coordinating cross-functional teams and guiding global CMC strategies.

The position supports a hybrid work model with relocation considerations to CA/NJ as needed. Relocation to Thousand Oaks, El Segundo, Foster City, or Parsippany is anticipated in 2027.