Regulatory Affairs Executive

Senior Regulatory Affairs Executive Salary: £30-35k Location: Easy commute from - South East/ Hertfordshire/ Cambridge/ London/ Uxbridge/ Watford, 30 minutes train from Kings Cross A minimum of 3 years relevant European Regulatory Affairs, ideally in a generics environment. Experience of Decentralised Procedure and Mutual Recognition procedure is required. * Experience dealing with the MHRA and other agencies * Will assist the Head of Regulatory Affairs to implement the Regulatory Affairs strategy for the EU. * Will Follow MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch. * Will liaise with external companies with respect to in-licensing and out-licensing activities and any associated regulatory issues as required. * Will complete dossier submissions for projects in a timely manner. * Will manage the submission process (generally DCP, MRP, CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory Procedures. * Excellent written and verbal communicator with a keen eye for detail. Good team working skills, able to influence in order to achieve objectives If you are keen to hear more infomation on this role or any other roles please contact Natalie Hopkins on 02077587311

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com/uk