Global Regulatory Affairs AssociateWe're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specializing in OTC products!
Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Associate will be responsible for assisting in the preparation and submission of regulatory documents to regulatory agencies.
He/she will ensure compliance with applicable regulations and standards.RESPONSIBILITIESAssist with the preparation and submission of regulatory documents to regulatory agenciesAssist in the preparation and submission of responses to regulatory agency inquiriesPrepare submissions of licence variations, notifications and renewals to strict deadlinesMonitor and set timelines for licence variations, notifications and renewal approvalsEnsure compliance with regulatory requirements and guidelinesMonitor and update regulatory documentation as necessary to keep the company in compliance from a regulatory perspectiveParticipate in meetings with regulatory agencies as neededParticipate in meetings with manufacturers as neededAdvise manufacturers on regulatory requirementsDocument and track regulatory submissions and regulatory authority approvalReview, proofread, and approve artwork of packaging materials to ensure compliance with regulatory requirementsPrepare Summary of Product Characteristics, Patient Information Leaflets, and labelling according to the Quality Review Documents (QRD) formatProvide ongoing regulatory support to the Regulatory Affairs Manager(s) and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectivesKeep up to date with national and international legislation and guidelinesMaintain RA archives (electronically)EXPERIENCE PROFILEScientific background is a must – master's degree in pharmaceutics, health care, life sciences or related fields preferred2+ years of experience in a similar role, preferably in an international environmentExcellent planning and time management skillsGood knowledge of relevant European guidelines, applicable legislation, and regulationsFluent communication skills in English (written and oral); Dutch is an asset.Personality: determined, persuasive, assertive, and communicativeCOMPETENCIESStrong team player, with the ability to work effectively in a team setting and interact with people of different seniority and functional backgroundsAbility to work independently and as part of a teamAbility to offer and accept ideasHighly ethical, honest, reliable, accountable, and loyalAbility to handle and enjoy complex and changing environmentsPositive "can do" attitudeAbility to consistently meet deadlines, remain organized, adaptable, and autonomousGood communication and presentation skillsEnglish language skills (spoken and written); Dutch is a bonusAbility to work concurrently on projects, each with specific instructions that may differ from project to projectIf this role sounds interesting to you, then please apply or reach out to ****** #J-18808-Ljbffr