Reglatory Affairs Manager job in Newry at V Selective Recruitment
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Reglatory Affairs Manager

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Company: V Selective Recruitment

Location: Newry, Northern Ireland

Date Posted: Jan 30, 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 - 30 Jan 2012
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