One of EPM Zurich's key accounts in the Bern area is currently searching for Regulatory Affairs Consultant for a 6 month contract.
This company is a leader within Biotech in the area of Vaccines. This is a fantastic opportunity to join a growing company with great culture.
- Prepares regulatory documentation for submissions such as variations, renewals, etc. in a timely manner.
- Responsible for the good quality and conformity of the submissions to Swiss and EU regulatory requirements.
- Approves and drafts texts (e.g. summaries, linking texts, labels and leaflets, letters). Reviews and comments on documents from other departments.
- Communication and Collaboration with Contract Manufacturers.
- Answer Health Authority inquiries according to timelines.
- Planning, compilation, submission in collaboration with internal publishing team.
- Submission tracking, Archive submissions and source documents by country.
- Proof reading of Packaging Materials (mockups, Cartons, PIL).
Please apply directly or reach out to Finlay McLellan via Linkedin