Regulatory Affairs Specialist - 5 months contract Nr ref.: /JOBS.pl ProClinical are currently recruiting for a Regulatory Affairs Specialist with a focus on CMC and API submission on behalf of our client. Our client is part of a leading global pharmaceutical organization and specialized in pharmaceuticals and medical devices. The role will be based in the German part of Switzerland and is a 5 month contract.In this regulatory function you will perform and support activities to ensure regulatory filing compliance as a basis to support the business for APIs manufacturing process.Job Responsibilities: Submissions, Coordination and preparation for new submissions, regular updates, variations, renewalsCustomer communication (prior and after submission of regulatory filings and/or filing updates filing)Regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawalsCoordination and preparation of responses to deficiency letters or authority requestsRegulatory assessments of Change Requests and development of regulatory implementation planRegulatory consultation for Quality Assurance, Production, Quality Control, Sales, PurchasingEnsure regulatory filing compliance and continued lifecycle management Job Requirements: A minimum of a Bachelor's degree Minimum of 6+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry).Regulatory CMC or CMC experience is preferred.Basic knowledge of regulatory requirements is preferred.Drug development experience is preferred.A working knowledge of global HA laws, regulations, and guidance is required.Experience developing regulatory strategies and an understanding of product development is preferred.Knowledge in German is preferred but not absolutely required If you would like to apply for this role, please send your CV to Beata Klecz on or call . A full job description is available on request. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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