Regulatory Affairs Manager

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Regulatory Affairs Manager -Medicinal Products & Food SupplementsLocation: Basel Tasks: Ensure that regulatory activities are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholdersEnsure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the products under his/her responsibilitySupport in the provision of expert regulatory input to strategic decision makingWrite comprehensible, clear Regulatory Assessments and documents for internal and external stakeholders (e.g. Authorities and trade Associations)Ensure that regulatory submissions and other deliverable meet strict deadlines and fulfil European regulatory standardsKeep up-to-date with changes in regulatory legislation and guidelinesSupport in the development and implementation of regulatory standards that convey the best practices in the regulatory departmentEstablish strong relationships within the European Division, Regulatory Operations and Global Partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, R&D, Regulatory and Product SafetyProvide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the Regulatory Affairs Managers in the hubs in topics related to the products and projectsProvide assistance to authority inspections in the matters under Regulatory responsibilityEnsure the review and approval of artworks and ingredient lists for products and regionsProvide input for budget preparation and reviewsCollaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her (e.g. implementation of new IT systems, review and update of SOPs, etc)Contribute to an effective use of the network of regulatory consultants, including coordination with procurement and legal for contract negotiations and FCPA and Due Diligence processesRequirements:Degree in a relevant scientific discipline (minimum BSc or equivalent, preferably with an MSc).Fluent in English and another European language.Good analytical skills and technical/ scientific competenceStrong organizational skillsTeam player, proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusionThorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of medicinal products and the technical file (and ideally also medical devices, or other complex legislations)Sthree Switzerland is acting as an Employment Business in relation to this vacancy.