Regulatory Affairs Senior Associate

About the RoleWe are seeking a highly skilled Regulatory Affairs Senior Associate to join our team at Tampa Gardens Senior Living. As a key member of our regulatory team, you will be responsible for providing European regional regulatory leadership and expertise for the development, registration, and lifecycle management of our products.Key ResponsibilitiesExecute the regional regulatory strategy and regional regulatory plans.Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.Use of Amgen systems and document management.Ensure and support regulatory product compliance.Work with policies and SOPs.Build effective relationships and communication paths across local and functional organizations.Enable efficiencies and seamless execution across the region countries.RequirementsMaster's degree (scientific area) OR Bachelor's degree (scientific area) and 2 years of directly related experience.Preferred knowledge: Degree and in-depth regulatory experience and/or related to the region.Depth knowledge of regional countries legislation and regulations related to medicinal products.What We OfferVast opportunities to learn, develop, and move up and across our global organization.A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, try new things, and act.Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
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