Regulatory Affairs / Licensing Manager job in Newry And Mourne at Morgan Turner Recruitment
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Regulatory Affairs / Licensing Manager

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Company: Morgan Turner Recruitment

Location: Newry, Down

Date Posted: Jan 26, 2012

Lead multiple regulatory project teams Plan and conduct regulatory projects including management of resources, training, technology and reporting Provide project and administrative oversight including forecasting, budgeting and reporting Criteria: PhD in a scientific field plus > 10 years relevant regulatory experience, including at least 5 years managerial experience In-depth experience in pharmaceutical regulatory affairs with knowledge of investigational and marketed products, including EMA and FDA liaison experience Knowledge of medical products and veterinary medicinal products, devices, biologics, biosimilars, generics, OTC products is desirable Experience authoring and reviewing CMC, Effectiveness and Safety regulatory submission documents Experience in co-ordinating Centralised, Decentralised and Mutual Recognition applications for Europe and NADA and ANADAs for USA is essential Experience of Regulatory Affairs across all stages of Development and Life Cycle Management...View full job description
From CV Library - 26 Jan 2012
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