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Regulatory Affairs Manager Pfäffikon Switzerland,  


Posted on : 08 March 2017

Project Description

ACCOUNTABILITIESCommunication with the authority (Swissmedic) and the head officeMarketing Authorization Applications for new productsOrphan Drug ApplicationsDevelopment of regulatory strategies for new products and the timely provision of documents for Swissmedic in collaboration with the Senior Regulatory Affairs ManagerContinuous maintenance of marketing authorizations for all medicinal products (Life-Cycle Management)Preparation and submission of variations concerning the approved products (Quality-, Labelling changes, &)Safety submissions, e.g. Periodic Safety Update Report (PSUR)Provision of packaging material: revision, translation, proofreading and publication of professional and patient informationContinuous updating of the product information to be in line with the current CCDSEnsure high quality professional communication when responding to medical inquiriesSet-up standardized answers for FAQ (frequently asked questions) or routine requests in collaboration with medical advisors and medical science liaisonsSupport in creation and maintenance of promotional materialsReview of promotional materials and their monitoring for conformity and compliance with regulatory requirementsCOLLABORATION WITH OTHER POSITIONSIn-house: - All Departments within the LOCInternal: - Global Regulatory AffairsExternal:-Swissmedic (Authority)QualificationsEDUCATION, EXPERIENCE & SKILLSPharmacist or life science degreeGerman (must), English (must), French good knowledgeMS-OfficeAdobe ProfessionalTeam workCommunicationPro-active attitude *LI-RL1-EURScheduleFull-time

Locations

Pfaeffikon Zurich Switzerland

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