Senior Regulatory CMC Lead — Viral Vector Therapies

Kite Pharma; Hoofddorp; On-site; EUR 120,000 - 160,000; Full time

Job summary

Kite Pharma seeks an experienced Regulatory Affairs CMC Lead to manage regulatory CMC deliverables for assigned cell therapy programs, ensuring alignment with EMA/EU requirements and RoW strategies. This is a senior, cross‑functional leadership role.

The candidate should have 8+ years in Regulatory Affairs, advanced degrees (PhD/MS preferred), and strong interaction with Health Authorities, global teams, and internal IT systems. Dutch language skills are a plus.

Qualifications

• Regulatory Affairs experience in CMC for cell therapy; EMA/EU RoW knowledge.
• 8+ years experience post-Bachelor in Regulatory Affairs.
• Experience drafting and reviewing CMC documentation.

Responsibilities

• Act as the Regulatory Affairs CMC Lead for assigned clinical and commercial cell therapy programs, ensuring high-quality and timely regulatory CMC deliverables.
• Contribute to the development and execution of CMC regulatory strategies, aligned with product development stage, regional requirements, and overall program objectives.
• Author, review, and critically assess regulatory CMC documentation, ensuring accuracy, consistency, and compliance.
• Provide regulatory CMC guidance and input to cross-functional teams to support product development, lifecycle management, and commercialization activities.
• Interpret and apply EMA, EU, Ph. Eur., and relevant RoW regulatory requirements, with a strong understanding of ATMP-specific expectations and practical implementation.
• Support alignment of cross-functional perspectives into a consistent regulatory CMC position, balancing compliance, timelines, and operational feasibility.
• Assess and evaluate proposed CMC change controls to determine their regulatory impact across clinical and commercial programs.
• Ensure internal regulatory IT systems are kept accurate, up to date, and aligned with regulatory activities, enabling reliable tracking of submissions, status, and commitments across programs.
• Participate in industry trade groups and regulatory professionals associations.
• Take a leadership role in updating the corporation on major international CMC regulatory guidance for assigned areas of interest.
• Will be expected to use industry network to maintain an awareness of the “pulse” of CMC best practices, and to disseminate this information to the corporation.
• Assist in drafting background packages for meetings with Health Authorities, and may be required to develop basic strategies.
• Form ad hoc task forces to address critical CMC issues on behalf of project and department teams"],
• CoT_job_summary_short
• COMPANY NAME: Kite PharmaKEY POINTS: Regulatory CMC leadership, EMA/EU expertise, cross-functional collaboration
• job_summary_short":"<p>Kite Pharma seeks an experienced Regulatory Affairs CMC Lead to manage regulatory CMC deliverables for assigned cell therapy programs, ensuring alignment with EMA/EU requirements and RoW strategies. This is a senior, cross‑functional leadership role.</p><p>The candidate should have 8+ years in Regulatory Affairs, advanced degrees (PhD/MS preferred), and strong interaction with Health Authorities, global teams, and internal IT systems. Dutch language skills are a plus.</p>",
• contract_type
• fulltime
• location_type
• on site
• remote_scope":null,

Skills

Regulatory knowledge

Cross-functional leadership

Influence stakeholders

Technical writing

English proficiency

Dutch language

Organizational skills

Software proficiency

Education

Advanced degrees (PhD/MS)

Job description

Kite Pharma seeks an experienced Regulatory Affairs CMC Lead to manage regulatory CMC deliverables for assigned cell therapy programs, ensuring alignment with EMA/EU requirements and RoW strategies. This is a senior, cross‑functional leadership role.

The candidate should have 8+ years in Regulatory Affairs, advanced degrees (PhD/MS preferred), and strong interaction with Health Authorities, global teams, and internal IT systems. Dutch language skills are a plus.