Manager, Regulatory Affairs CMC with Viral Vector experience
In English
About the job
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.
What you will do
- 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
What you bring
- 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
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 Kite Pharma's website (gilead.wd1.myworkdayjobs.com); Apply takes you straight there.