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Regulatory Affairs Manager United Kingdom,  


Posted on : 13 May 2017

Project Description

Title:Regulatory Affairs ManagerThe company:Amgen is one of the world s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally. For more than 35 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.The Role:Reporting to a Regional Group Leader, this role will support one or more products from a regional (extended Europe) regulatory perspective.The incumbent will ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.ResponsibilitiesStrategy and ExecutionPlans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.Provides content guidance for regional regulatory documents and meetings in accordance with global strategyProvides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)Supports regional label negotiation activitiesUnder general supervision participate in the development, and execution of regional regulatory product strategiesObtains and maintains Clinical Trial Authorizations including Response to QuestionsCommunicates regulatory strategies within teamUnder general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agenciesRegulatory Research Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Under supervision evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labellingLocation:This role can be based in either the Uxbridge or Cambridge office.Remuneration:Competitive salary & comprehensive benefits package including bonus scheme.Basic qualifications:Scientific Degree and demonstrated experience in a similar roleRegulatory principlesWorking with policies, procedures and SOP sKnowledge of legislation and regulations relating to medicinal productsAwareness of the registration procedures in region for MA, post approval changes, extensions and renewals.Knowledge of drug developmentKnowledge of and experience in regional regulatory environmentTeam workCommunication skills - both oral and writtenAbility to understand and communicate scientific/clinical informationAbility to anticipate and prevent potential issuesAbility to resolve conflicts and develop a course of action leading to a beneficial outcomePreferred Qualifications:MSc/PhD in Life SciencesExperience interacting with regulatory agenciesKnowledge of and experience in regional regulatory environment in relevant product area and development stageCultural awareness and sensitivity to achieve results across both regional country and International borders.Amgen is an equal opportunities employer.HJE2017

Locations

United Kingdom Uxbridge; United Kingdom Cambridgeshire

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