Vacature detail

(Junior) Regulatory Affairs Manager
House of Talents
Jobomschrijving The (Jr) Regulatory Affairs Manager works under the hierarchical supervision of the Head of Regulatory Affairs.The Regulatory Affairs Manager operates within the Regulatory Affairs Unit (RAU) to ensure that all the regulatory requirements pertaining to clinical research are fulfilled.Prepare master packages for international clinical trial applicationsProvide regulatory advice to staff on applicable legislations (international and national) and regulatory proceduresCompile, submit and follow-up clinical trial applications according to applicable national lawsEnsure timely answers to questions raised by Competent Authorities and Ethic CommitteesInteract with Pharmaceutical Industry and Contract Research Organizations (CRO) for specific projectsEnsure at any time compliance with procedures in changing legal environmentContribute to and maintain databases for assigned trials.Contribute to training/coaching of new regulatory team members Profiel Master’s degree in life sciences or related field1-5 years’ prior experience including demonstrable experience in Site activation/Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry) or equivalent combination of education, training and experienceFamiliar with the EU Clinical Trials Regulation N° 536/2014 and knowledgeable on the new upcoming European regulationsAbility to cope with and meet tight timelines when requiredAble to manage multiple tasks at the same timeAble to work independently as well as part of a teamDemonstrated good organization, communication and time-management skillsExcellent attention to detail and accuracyProficient verbal and written English, other language is an asset Aanbod Een competitief salarispakket samen met: 30 vakantiedagen, DKV hospitalisatie werkgever, gratis parking, volledige terugbetaling openbaar vervoer, maaltijdcheques en pensioenplan.
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West-Vlaanderen, Kortrijk
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