**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
We are currently seeking a **Regulatory Affairs (RA) Specialist **to join Biosciences Division Regulatory Affairs Team. As a member of the RA team, you will be planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.
**Key responsibilities**:
- Support of activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time).
- Serving as the liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal.
- Collecting, consolidating and ensuring accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets).
- Crea...