Regulatory Affairs Coordinator
vor 22 Stunden
**Regulatory Affairs Coordinator 4881 SRS**
As the Regulatory Affairs Coordinator you will support the Regulatory team in managing, tracking and archiving regulatory requests received from our partners companies in their respective territories.
**Main Responsibilities**:
- Ensuring all documents/declarations/statements are signed by company representatives and contract manufacturers
- Managing requests for notarized/apostilled documents, CPPs from Heath Authorities, Deficiency letters and eCTD modules
- Coordinating the Regulatory requests
- Collecting, tracking and filing partners’ regulatory assessment and submission status of the changes in the business partners’ territories.
- Filing existing Regulatory documents e.g. Correspondence, Submissions, Approvals, Deficiency Letters, Meeting Minutes etc. and maintains Regulatory trackers to ensure these are up-to-date.
**Qualifications and Experience**:
- **Relevant Swiss working/residency permit or Swiss/EU-Citizenship required**:
- Regulatory Affairs, experience >5 years
- Previous working within Pharma and Regulatory Affairs
- Excellent communication in English is essential, German and Spanish, preferable
- Hands-on experience in Document Management System (DMS) and eCTD publishing
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