Regulatory Affairs CMC Lead, Viral Vector Therapies

Kite Pharma; Hoofddorp; On-site; EUR 90,000 - 130,000; Full time

Job summary

Kite Pharma, a biopharmaceutical company focused on CAR T therapies, seeks a Regulatory Affairs CMC Lead to oversee regulatory CMC deliverables for clinical and commercial cell therapy programs in the EU and RoW. The role is based in the Netherlands, Hoofddorp area, with close collaboration across biology, manufacturing, and quality teams.

The position requires 8+ years in Regulatory Affairs, advanced degrees, and strong cross-functional collaboration.

Qualifications

• Sound understanding of regulatory requirements including ICH and regional requirements across EMA/EU and RoW.
• Proven ability to drive cross-functional deliverables and influence stakeholders without direct authority.
• Excellent written and verbal communication of regulatory, scientific or technical documents.
• English fluency required; Dutch proficiency a plus.

Responsibilities

• Act as the Regulatory Affairs CMC Lead for assigned clinical and commercial cell therapy programs.
• Contribute to development and execution of CMC regulatory strategies aligned with product development stage and regional requirements.
• Author, review, and assess regulatory CMC documentation for accuracy and compliance.
• Provide regulatory CMC guidance to cross-functional teams to support development, lifecycle management, and commercialization.
• Interpret EMA, EU, Ph. Eur., and RoW requirements with ATMP-specific considerations.
• Support alignment of cross-functional perspectives into a single regulatory CMC strategy.
• Assess proposed CMC change controls for regulatory impact across programs.
• Maintain internal regulatory IT systems with accurate submissions tracking.

Skills

Regulatory knowledge

Cross-functional collaboration

Technical writing

Regulatory strategy

English proficiency

Education

PhD or MS in relevant field

Job description

Kite Pharma, a biopharmaceutical company focused on CAR T therapies, seeks a Regulatory Affairs CMC Lead to oversee regulatory CMC deliverables for clinical and commercial cell therapy programs in the EU and RoW. The role is based in the Netherlands, Hoofddorp area, with close collaboration across biology, manufacturing, and quality teams.

The position requires 8+ years in Regulatory Affairs, advanced degrees, and strong cross-functional collaboration.