Manager, Regulatory Affairs CMC with Viral Vector expe…

In this Regulatory Affairs CMC Lead role, you will guide regulatory CMC strategy for Kite’s cell therapy programs to ensure compliant, timely submissions. You will partner with cross-functional teams to align development plans with regional requirements and program objectives, shaping how therapies reach patients. You’ll translate complex CMC considerations into practical guidance, and keep internal systems and stakeholders updated with the evolving regulatory landscape. This is a high-impact role at the forefront of cancer immunotherapies.

• Lead regulatory CMC strategy for assigned cell therapy programs across clinical and commercial stages
• Draft, review, and ensure accuracy of CMC regulatory documentation
• Provide CMC regulatory guidance to cross-functional teams supporting development, lifecycle management, and commercialization
• Interpret EMA, EU, Ph. Eur., and RoW requirements with emphasis on ATMP expectations
• Align cross-functional perspectives into a coherent CMC strategy balancing compliance and timelines
• Assess CMC change controls for regulatory impact across programs
• Maintain accuracy of regulatory IT systems tracking submissions, status, and commitments
• Engage in industry groups and disseminate CMC best practices internally
• Update the corporation on major international CMC regulatory guidance
• Form ad hoc task forces to address critical CMC issues
• Draft background packages for Health Authority meetings and contribute to basic strategies
• Lead initiatives and communicate regulatory updates to stakeholders

• 8+ years in Regulatory Affairs or relevant industry experience after a Bachelor’s Degree
• Experience with viral vectors and/or lipid nanoparticles
• Sound understanding of ICH and regional regulatory requirements, with knowledge of global trends in Regulatory Affairs CMC
• Proven ability to drive cross-functional deliverables and influence without direct authority
• Strong written and verbal English communication; Dutch proficiency a plus
• Excellent organizational skills, attention to detail, and ownership mindset
• Ability to operate in a fast-paced environment with shifting priorities
• Experience with regulatory IT systems and submissions tracking
• Experience with Health Authority interactions and basic strategy development
• Proficiency with industry-standard software tools

• cross-functional collaboration
• influence without authority
• clear scientific and regulatory communication
• CMC regulatory strategy
• EMA/EU/Ph Eur/RoW regulation interpretation
• ATMP regulatory expectations