Regulatory Affairs Coordinator

vor 2 Wochen


Basel, Schweiz CTC Resourcing Solutions Vollzeit

**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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