RA Manager ATMP (CMC/Non-Clinical)
Our client is a start-up company that creates and develops next generation Gamma/Delta T cells for the treatment of cancer. There are currently expanding their office for setting up clinical trials phase 3.
Within this role you will be in charge for CMC writing regarding regulatory guidelines on New Biological Entities. Preparing regulatory submissions including ECTD, IMPD, CTA and IND and documents for regulatory agencies with a focus on CMC (Module 2 / 3)
- You make sure that all regulatory guidelines are up to date. And you will share this with R&D.
- You will connect health authorities.
- You will provide input in the development programs to succeed phase 1 and phase 2 for new biological drugs.
- You will be the one who is responsible for setting up a document management system.
- You will review development reports for regulatory compliance.
- MSc or PhD in biotechnology, biology or related sciences
- A minimum of 3 years of experience in a similar role in the (bio)pharmaceutical industry
- You are a excellent project manager
- You are fluent in English, Dutch is an asset
- Able to travel if necessary