Global Regulatory Associate

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Global Regulatory (Global Product Strategy)Company is a global leader in the plasma protein biotherapeutics to treat rate conditions.ContractStart: ASAPUntil: 30th June 2022 + high potential extensionLocation: 99% remote (home office) in Switzerland (or Germany / France). Ideally requested to work from Switzerland Very international: Hiring Manager located in USA Role description: Provide expertise to the Global Regulatory Affairs by: Owning the documentation of the regulatory components of aggregate safety reportsEnsuring GRA engagement in aggregate safety report development and maintenanceEnsuring execution of aggregate safety report submissions to Health Authorities according to strategyResolves and aligns internal GRA functions inputs for aggregate safety reports and questions from health Authorities Qualification and Experience:Regulatory Affairs expert with 5 years of regulatory experience in a global capacity within the pharmaceutical industryExperience with life-cycle management of marketed productsDirect management of health authority interactions including responding to queries and RFIs, marketing authorization applications, aggregate safety reporting (PSURs, DSURs, IND annual reports, 120-day safety reporting, etc.), and post-marketing maintenanceIt would also be helpful to have an experience working in document management systems (e.g. Documentum)Sthree Switzerland is acting as an Employment Business in relation to this vacancy.