Job Description

A Specialist profile will ensure efficient project execution, better quality outcomes, and reduced dependency on supervision. Therefore, hiring a Specialist is essential to meet the role requirements effectively.\n\nMAIN ACTIVITIES FOR THE JOB\n\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.\nSupport for Initial MA application, all kind of LCM activities.\nAct as (Single) Point of Contact and oversee clients’ portfolios.\nCross-functional co-ordination.\nCommunication with external vendors.\nCommunication/Co-ordination with client and participate in client’s meeting, preparing MoM etc.\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.\nAssess regulation and inform the clients about the impact on their products or activities.\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 Team. Lead and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.\nContribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub.\nControl that invoicing is correctly set.\n\nAssist the RA Platform or Hub Leader or Coordinator in presales:\nEnsure providing technical support to presales\nEnsure adequate technical description of the proposals and support sales for quotation evaluation\n\nEnsure that invoicing is done correctly.\nContribute to the input of data into PLG tools enabling\nKPI/metrics for regulatory services provided by the platform/hub.\n\nRequired education:\nBachelor’s or higher degree in a science related field, or equivalent experience.\n\nRequired experience:\n7-8 years of EU RA technical and project management experience.\n\nRequired languages:\nGood English language and grammar skills (written fluency a must, verbal fluency preferred)\nAny 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