Regulatory Affairs Assistant - Junior

Recruiter
ProClinical Ltd
Location
Buckinghamshire
Posted
08 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Junior Regulatory Affairs Assistant based in High Wycombe. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.To support product registration activities and product registration submissions throughout the world, in order that registrations are achieved in a timely manner in accordance with regulatory and Company requirementsJob Responsibilities: * Provide full support to all registration activities and regulatory submissions throughout the world. * Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies. * Maintain information on worldwide regulatory requirements and the status of product registrations. * Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals. * Utilise various information source to obtain large volumes of information. Collate information and reformat to meet world-wide Regulatory formats. * To be aware of progress and developments of worldwide regulatory requirements. * To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results. * Reports directly to the Regulatory Manager, RALI and co-ordinates with the other Regulatory Affairs Associates. * Liaise with personnel in all departments including global regulatory partnersSkills and Requirements: * A good first degree in a relevant scientific discipline, or equivalent. * 1 - 5 years Regulatory experience covering medical devices * Possess computer competency in Microsoft office software, data collection and general analysis tools. * Excellent PC skills (Microsoft Office Package). * Excellent written and verbal reasoning skills. * Excellent planning and organisational skills. * Communication - listener, learner and thinker. * Product awareness and thorough knowledge of respective regulatory frameworks. * Thorough and flexible. * Cross culturally aware. * Team player * Enthusiastic and committed.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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