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
Manager, Regulatory Affairs CMC with Viral Vector experience in Hoofddorp werkgever: Jobrapido
StarPark is een uitstekende werkgever die je de kans biedt om te werken op diverse evenementen en festivals, waar je in een informele en prettige werksfeer kunt bijdragen aan de veiligheid van bezoekers. Met flexibele werkmogelijkheden en goede begeleiding vanuit het team, stimuleert StarPark persoonlijke groei en ontwikkeling, waardoor je niet alleen waardevolle ervaring opdoet, maar ook de mogelijkheid hebt om door te groeien binnen de organisatie. Wij verwelkomen iedereen, ongeacht achtergrond, en geloven dat jouw talent het belangrijkste is.
