Regulatory Affairs CMC Manager, Cell Therapy

Gilead Sciences Inc.; Thousand Oaks (CA); Híbrido; USD 133.000 - 172.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus eligibility

Stock incentives

Paid time off

Benefits package

Descripción de la vacante

Kite Pharma is seeking a Manager, Regulatory Affairs CMC to lead regulatory submissions and lifecycle management for LVV and cell therapy products. The role involves coordinating across MSAT, Quality, Manufacturing, and Supply Chain to develop regulatory strategies and respond to health authority inquiries.

The position is office-based with a hybrid arrangement, located in multiple sites including Thousand Oaks, CA, El Segundo, CA, Foster City, CA, or Parsippany, NJ, with relocation

Formación

• Foundational knowledge of CMC regulatory requirements and ICH guidelines.
• Strong written and verbal communication skills.
• Attention to detail and strong organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Effective cross-functional collaboration.
• Proactive and solution-oriented mindset.

Responsabilidades

• Prepare and support regulatory submissions (INDs, CTAs, BLAs, MAAs, supplements, variations).
• Contribute to LVV and cell therapy regulatory strategies and lifecycle management.
• Coordinate with LVV process development, manufacturing, analytics, and Quality teams.
• Support health authority interactions and responses to information requests.
• Assess regulatory impact of changes to LVV manufacturing, materials, and site updates.

Conocimientos

CMC knowledge

Communication skills

Attention to detail

Multitasking

Cross-functional collab

Proactive mindset

Educación

Bachelor’s degree with Six Years' experience

Master’s degree with Four Years' experience

Descripción del empleo

Kite Pharma is seeking a Manager, Regulatory Affairs CMC to lead regulatory submissions and lifecycle management for LVV and cell therapy products. The role involves coordinating across MSAT, Quality, Manufacturing, and Supply Chain to develop regulatory strategies and respond to health authority inquiries.

The position is office-based with a hybrid arrangement, located in multiple sites including Thousand Oaks, CA, El Segundo, CA, Foster City, CA, or Parsippany, NJ, with relocation