Manager, Regulatory Affairs CMC with Viral Vector experience
In English
About the job
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.
What you will do
- 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
What you bring
- 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
Nice to have
- Advanced degrees (PhD or MS)
- Proficiency in Dutch
Summary by Personeel.com. The full job description and the application form are on Gilead Sciences's website (gilead.wd1.myworkdayjobs.com); Apply takes you straight there.