Hybrid CMC Regulatory Affairs Manager (CAR-T/LVV)

Kite Pharma, Inc.; El Segundo (CA); Híbrido; USD 133.000 - 172.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Stock options

Discretionary bonus

Descripción de la vacante

Kite Pharma, Inc. is recruiting for a Manager, Regulatory Affairs CMC to drive CMC regulatory activities for LVV and cell therapy products.

The role is hybrid with relocation considerations to Thousand Oaks, CA or El Segundo, CA, and includes collaboration across Process Design, MSAT, Quality, and Manufacturing teams. The position emphasizes global regulatory strategy development, lifecycle management, and health authority interactions, with a focus on LVV manufacturing processes and control

Formación

• Bachelor’s degree with 6+ years' experience or Master’s degree with 4+ years' experience.
• Experience with cell and gene therapy / LVV programs, including regulatory strategy and lifecycle management.
• Experience supporting regulatory submissions and health authority interactions

Responsabilidades

• Support preparation and submission of regulatory filings for CMC in cell therapy programs.
• Contribute to global regulatory strategies under guidance for LVV and cell therapy products.
• Collaborate cross-functionally with MSAT, Quality, Manufacturing, and Supply Chain to support regulatory deliverables.
• Maintain regulatory records and support inspections and responses to information requests.
• Identify regulatory risks and contribute to mitigation strategies for evolving guidelines.

Conocimientos

CMC regulatory knowledge

Regulatory submissions

Cross-functional collaboration

Communication skills

Attention to detail

Educación

Bachelor's degree in a scientific discipline

Master's degree in a scientific discipline

Descripción del empleo

Kite Pharma, Inc. is recruiting for a Manager, Regulatory Affairs CMC to drive CMC regulatory activities for LVV and cell therapy products.

The role is hybrid with relocation considerations to Thousand Oaks, CA or El Segundo, CA, and includes collaboration across Process Design, MSAT, Quality, and Manufacturing teams. The position emphasizes global regulatory strategy development, lifecycle management, and health authority interactions, with a focus on LVV manufacturing processes and control