Manager, Regulatory Affairs CMC with Viral Vector experience
Engelstalig
Over de functie
Gilead Sciences is seeking a Manager for Regulatory Affairs CMC with viral vector experience to lead cell therapy programs in Hoofddorp. You will develop and execute CMC regulatory strategies, author documentation, and provide guidance to cross-functional teams.
Wat ga je doen
- Act as Regulatory Affairs CMC Lead for cell therapy programs
- Develop and execute CMC regulatory strategies
- Author and review regulatory CMC documentation
- Provide regulatory CMC guidance to cross-functional teams
- Interpret EMA, EU, Ph. Eur., and RoW regulatory requirements
- Assess CMC change controls for regulatory impact
Wat je meebrengt
- Relevant industry experience with viral vectors or lipid nanoparticles
- 8+ years in Regulatory Affairs or relevant experience after Bachelor's Degree
- Sound understanding of ICH and regional regulatory requirements
- Proven ability to drive cross-functional deliverables
- Excellent command of English, written and verbal
- Strong 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 Gilead Sciences (gilead.wd1.myworkdayjobs.com); met Solliciteer ga je er direct heen.