Hybrid CMC Regulatory Affairs Manager

Kite Pharma, Inc.; El Segundo (CA); Hybride; USD 133 000 - 190 000; Plein temps

Avantages offerts par ce poste

discretionary annual bonus

discretionary stock-based long-term

paid time off

benefits package

medical

dental

vision

life insurance

Résumé du poste

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to lead regulatory submissions and lifecycle activities for LVV and cell therapy programs.

This office-based/hybrid role is located in El Segundo, CA with relocation consideration to Thousand Oaks, CA, or other listed sites. The position requires a strong CMC regulatory background, excellent communication, and cross-functional collaboration to support health authority interactions and global strategies.

Qualifications

• 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.

Responsabilités

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations).
• Contribute to Module 3 (CMC) content development aligned with global regulatory requirements for LVV and materials.
• Assist in execution of global CMC regulatory strategies under guidance for cell therapy products and LVV manufacture.
• Partner with LVV process development, manufacturing, QA, MSAT, and supply chain teams to support regulatory deliverables.
• Support health authority interactions and prepare responses to information requests and meeting materials.
• Assess change controls for regulatory impact and support lifecycle management activities for LVV processes and materials.
• Support manufacturing changes, comparability, and site updates for cell therapy and LVV operations.
• Contribute to inspection readiness with documentation for LVV and cell therapy facilities.
• Maintain regulatory records in relevant systems related to LVV manufacturing and compliance.
• Identify risks and contribute to mitigation strategies for evolving global regulatory expectations.
• Participate in continuous improvement and knowledge-sharing initiatives.

Connaissances

CMC knowledge

Regulatory communication

Attention to detail

Multi-priority management

Cross-functional collaboration

Proactive mindset

Formation

Bachelor's or Master's in Science

Description du poste

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to lead regulatory submissions and lifecycle activities for LVV and cell therapy programs.

This office-based/hybrid role is located in El Segundo, CA with relocation consideration to Thousand Oaks, CA, or other listed sites. The position requires a strong CMC regulatory background, excellent communication, and cross-functional collaboration to support health authority interactions and global strategies.