Manager, Regulatory Affairs CMC with Viral Vector experience
Engelstalig
Over de functie
Kite Pharma is seeking a Manager of Regulatory Affairs CMC to lead clinical and commercial cell therapy programs from their Hoofddorp location. In this role, you will develop and execute CMC regulatory strategies and provide guidance to cross-functional teams.
Wat ga je doen
- Act as Regulatory Affairs CMC Lead for clinical and commercial cell therapy programs
- Develop and execute CMC regulatory strategies
- Author, review, and assess regulatory CMC documentation
- Provide regulatory CMC guidance to cross-functional teams
- Interpret and apply EMA, EU, Ph. Eur., and RoW regulatory requirements
- Assess regulatory impact of CMC change controls
Wat je meebrengt
- Relevant industry experience with viral vectors or lipid nanoparticles
- 8+ years in Regulatory Affairs or relevant industry experience after Bachelor’s Degree
- Sound understanding of ICH and regional regulatory requirements
- Proven ability to drive cross-functional deliverables and influence stakeholders
- Strong written and verbal English skills
- Organizational skills with attention to detail
Mooi meegenomen
- Advanced degrees (PhD or MS)
- Proficiency in Dutch
Samenvatting door Personeel.com. De volledige vacaturetekst en het sollicitatieformulier staan op de website van Kite Pharma (gilead.wd1.myworkdayjobs.com); met Solliciteer ga je er direct heen.