Manager, Regulatory Affairs CMC with Viral Vector experience

Over de vacature

Overview

As Regulatory Affairs CMC Lead, you drive high-quality regulatory CMC deliverables for cell therapy programs and shape global strategies. You partner with cross-functional teams to align development, lifecycle management, and commercialization with regional requirements. You'll interpret EMA/EU/ATMP guidance and influence regulatory decisions while maintaining timelines and operational feasibility. This role sits at the core of advancing cutting-edge cancer therapies and shaping our regulatory posture across programs.

Verantwoordelijkheden

• Lead regulatory CMC deliverables for clinical and commercial cell therapy programs
• Develop and execute CMC regulatory strategies aligned with product development stage and regions
• Author/review regulatory CMC documents ensuring accuracy and compliance
• Provide CMC guidance to cross-functional teams for development, lifecycle management, and commercialization
• Interpret EMA/EU/Ph. Eur. and RoW requirements with ATMP expertise
• Align cross-functional perspectives into a coherent CMC regulatory position
• Assess CMC change controls for regulatory impact
• Maintain regulatory IT systems with accurate submission tracking
• Participate in industry trade groups and associations
• Update the organization on major international CMC regulatory guidance
• Leverage industry networks to disseminate CMC best practices
• Assist in drafting background packages for Health Authority meetings and basic strategies
• Form ad hoc task forces to address critical CMC issues

Belangrijkste vereisten

• 8+ years in Regulatory Affairs or relevant industry experience post-Bachelor's

• Experience with viral vectors and/or lipid nanoparticles

• Advanced degrees (PhD or MS) desired

• Sound understanding of ICH and regional regulatory requirements for assigned territories

• Ability to drive cross-functional deliverables and influence without direct authority

• Strong written/verbal English; Dutch language is a plus

• Attention to detail and strong organizational skills

• Comfortable in a fast-paced environment with changing priorities

• cross-functional collaboration

• influencing without authority

• clear scientific and regulatory writing

• CMC regulatory strategy development

• EMA/EU/ATMP regulatory knowledge

• Regulatory change control assessment

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