Regulatory Affairs Technician

hace 1 semana


Sant Cugat del Vallès, España AB-BIOTICS A tiempo completo

\愛いStudying scientific and legal documents组选 Gathering, evaluation, organizing, managing and collating information in a variety of formats. Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS). Maintaining familiarity with company product ranges. Planning, undertaking, and overseeing product trials and regulatory inspections. Keeping up to date with changes in regulatory legislation and guidelines. Analyzing complicated information, including clinical trial data. Offering advice about company policies, practices and systems. Obtaining marketing permission. Outlining requirements for labelling, storage and packaging. Using a variety of specialist computer applications. Liasing and negotiating with regulatory authorities. Providing advice about regulations to manufacturers/scientists. Writing comprehensible, user-friendly, clear product information leaflets and labels. Ensuring that quality standards are met and submissions meet strict deadlines. Preparing documentation. Experience in Pharma, OTC and pharmaceutical register* #J-18808-Ljbffr



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