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Director, Regulatory Affairs CMC, Intercontinental United Kingdom,  

Posted on : 01 May 2017

Project Description

About Amgen:Amgen is one of the world s leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. For more than 30 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.Group purpose: Strategic Regulatory Affairs CMC partner for key stakeholders in Global Regulatory Affairs and Safety (GRAAS) (Therapy Areas and Affiliates) and in Operations (Global & Int l Operations, Global & Int l Quality, Alliance Management & manufacturing sites) for CMC & GMP issues related to defined regions (CEE, MEA, LA and AP)Strategic partner for Global RA CMC Product teams in ensuring product development and supply chain strategies are aligned with regulatory/GMP requirements and limitations in defined regionsStrategic RA CMC partner for GRAAS Affiliates & Operations / Quality for the integration of manufacturing sites in defined regions into the Amgen network Key ResponsibilitiesEstablishment of appropriate RA CMC infrastructure (processes, templates, intelligence & policy databases) to enable successful regulatory approvals in defined regionsEstablishment of appropriate cross-functional processes, policies & standards to enable successful launch and supply continuity in defined regionsDevelop & leverage RA expertise in both CMC and Regional requirements to guide successful product development strategies & supply chain continuityAdvising Global Product Teams on regional RA CMC requirements influencing product strategyFacilitating key regional decisions which impact global product development and filing strategiesProviding recommendations regarding regional strategy to GRAAS (e.g. GRRC, GCRB) and Operations Senior Management (e.g. OGC) for endorsementRepresenting RA CMC at GRAAS (e.g. GEMST) and cross-functional governance forumsBasic qualifications Bachelor s degree in related discipline In depth experience of pharmaceutical/biotechnology or medical device industryBroad experience of Regulatory AffairsPreferred experience Regional language skillsSpecific expert experience in one or more of the defined Regions including Latin America, Canada, Middle East and AfricaBroad experience in Emerging Markets regulatory affairs, supporting complex submissions for both biotechnology and chemically-derived products. NOTE ON LOCATION:This role is open to applicants based in the following locations:Amgen UK, UxbridgeAmgen UK, CambridgeAmgen is an Equal Opportunities employer.HJE2017


United Kingdom Cambridgeshire; United Kingdom Uxbridge

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