Manager, Regulatory Affairs CMC

Kite, a Gilead subsidiary, seeks a Manager in Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapies. The role involves preparing regulatory submissions, developing CMC strategies, and collaborating across functions to support lentiviral vector manufacturing compliance and lifecycle management.

Responsibilities

• Prepare and support CMC regulatory filings including INDs, CTAs, BLAs, and supplements for cell therapy and lentiviral vector programs
• Develop Module 3 content aligned with global regulatory requirements for cell and gene therapies
• Coordinate with cross-functional teams to assess manufacturing changes and their regulatory impact
• Support health authority interactions including preparation of responses to information requests and meeting materials
• Maintain regulatory records and contribute to inspection readiness activities for manufacturing facilities

Requirements

• Bachelor's degree with six years of experience, or Master's degree with four years of experience
• Foundational knowledge of CMC regulatory requirements and ICH guidelines
• Working knowledge of lentiviral vector manufacturing, process controls, and analytical characterization
• Understanding of regulatory expectations for viral vector comparability and control strategy development
• Strong written and verbal communication with attention to detail and organizational skills
• Ability to manage multiple priorities and collaborate effectively across functions