On behalf of our client, a leading global biotech company based in Bern, Swisslinx is looking for a Submission Coordinator to support Global Regulatory Affairs department at the site.
This is a 12-months contract position with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
- Request and track submission documents
- Perform submission coordination as defined in the Global Submission Management Process
- Coordinate major changes submission in all regions in close collaboration with the submission team and owner
- Create the Submission Content Plan
- Coordinate the submission package assembly, create publishing requests and reviews
- Ensure timely submission by collaborating with Regional / Local Regulatory Representative
- Minimum 1-2 years of experience within Regulatory Affairs (including submissions)
- Regulatory or submission coordination experience is a plus
- Strong organizational and communication skills
- Knowledge of regulatory systems (i.e. RIMS, EDMS) and Microsoft 365 applications
For further information, please do not hesitate to contact Alina Peeva, Recruiter.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA