Regulatory Affairs CMC Manager – Cell Therapy (Hybrid)

Kite Pharma, Inc.; Pennsylvania; Ibrido; USD 133.000 - 172.000; Tempo pieno

Vantaggi offerti da questo lavoro

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Descrizione del lavoro

Kite Pharma, Inc. is seeking a Manager of Regulatory Affairs CMC to lead regulatory activities for lentiviral vector (LVV) based cell therapies. The role is office-based with hybrid eligibility and located in the United States (Philadelphia, PA; Thousand Oaks/El Segundo, CA), with relocation planned to CA offices in 2027.

Two days remote, three days onsite. Required are a Bachelor’s or Master’s degree and extensive experience in CMC regulatory submissions, LVV processes, and lifecycle

Competenze

• Bachelor’s or Master’s degree required with applicable years of experience
• Experience in regulatory CMC is preferred
• Strong written and verbal communication skills and attention to detail
• Ability to manage multiple priorities in a fast-paced environment

Mansioni

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations)
• Contribute to Module 3 (CMC) content development to align with global regulatory requirements
• Assist in execution of global CMC regulatory strategies under guidance of senior staff
• Partner with LVV process development, manufacturing, analytical testing, and quality teams to support regulatory deliverables
• Support health authority interactions and responses to information requests
• Assess change controls for regulatory impact and support lifecycle management
• Support manufacturing changes, comparability, and site updates for LVV and cell therapy
• Contribute to inspection readiness and maintain regulatory records

Conoscenze

Communication skills

Attention to detail

Multitasking

Cross-functional collaboration

Formazione

Bachelor's degree

Master's degree

Descrizione del lavoro

Kite Pharma, Inc. is seeking a Manager of Regulatory Affairs CMC to lead regulatory activities for lentiviral vector (LVV) based cell therapies. The role is office-based with hybrid eligibility and located in the United States (Philadelphia, PA; Thousand Oaks/El Segundo, CA), with relocation planned to CA offices in 2027.

Two days remote, three days onsite. Required are a Bachelor’s or Master’s degree and extensive experience in CMC regulatory submissions, LVV processes, and lifecycle