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Senior Associate Regulatory Affairs United Kingdom,  

Posted on : 01 May 2017

Project Description

Title: Senior Associate Regulatory AffairsLocation: Cambridge or UxbridgeAbout Amgen Amgen is one of the world s largest independent biotechnology companies, with a global turnover in excess of $18 billion and over 18,000 employees globally. 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.Role overviewThe Regulatory Professional under the direction of a Regional Regulatory Lead will lead, or provide assistance with, the creation and submission of regulatory documents, and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.Key responsibilitiesSupport regional regulatory filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory LeadCreate and maintain product regulatory history documents through IMR/RISE and appropriately archive all regulatory documents and agency communicationsEnsure compliance via timely submissions to regulatory agenciesCollaborate with CROs / partners to support site initiationCoordinate collection of functional documents in support of regulatory applicationsCoordinate QC of regulatory documentation (e.g. briefing packages)Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)Prepare regulatory packages and cross-reference letters to support investigator initiated studiesApprove drug shipment for Amgen and Investigator Initiated StudiesComplete regulatory forms to support agency communications (e.g. EudraCT)Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teamsSupport process improvement initiatives, standards development, and metricsAssist in template development and maintenanceRespond to specific requests from - and communicate relevant issues to - GRTDevelop Regulatory Position with teamsActively support regulatory complianceSupport the development and execution of GRT goalsBasic qualifications/skillsGraduate in related disciplineBroad EU clinical trial application experience is essentialUnderstanding of drug development process, e.g. clinical trial phasesStrong communication skills - oral and writtenOrganizational and time management skillsPreferred qualifications/skillsExperience in oncology therapeutic area (preferred)


United Kingdom Cambridgeshire; United Kingdom Uxbridge

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