Regulatory Affairs Officer

MAIN ACTIVITIES FOR THE JOB\nContribute to regulatory activities performed on the RA Platform/the Hub.\nRegulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.\nTo contribute to the production of client administrative documents and reports to be included in regulatory submissions.\nCompile, or supervise the compilation of regulatory dossiers in accordance with national requirements.\nSystems Management and Administration.\nDocument and track regulatory submissions and regulatory authority approval.\nGain regulatory authority approval.\nProvide regulatory support to clients and associate companies.\nLiaise with sponsor head-office and affiliate departments on regulatory issues.\nLiaise with external regulatory authorities as required.\nProvide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.\nReview tasks for, support and mentor Regulatory Affairs Associates.\nProvide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.\nSupporting seniors (RAS) for Initial MA application, all kind of LCM activities including minor/major variations, renewals, sunset clause, labelling changes, Article 61.3, MA transfers, Manufacturing etc.\nHave experience of preparing the Module 1 of pre and/or post approval applications.\nContribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub.\n\nRequired education :\nBachelor’s or higher degree in a science related field, or equivalent experience\n\nRequired experienc e:\n4-6 years of experience in RA European Regulation\n\nRequired languages:\nGood English language and grammar skills (written fluency a must, verbal fluency preferr\ned)Any other language on top of good English would be a plus\n\nRequired technical skills:\nGood computer skills and the ability to learn appropriate software\nGood understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.\n\nAdditional experience and/or skills:\nExcellent organizational and interpersonal skills\nAbility to work well within a team\nProcess orientated with good attention to detail