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Regulatory Affairs Technician

icon building Empresa : AB-Biotics, S.A.
icon briefcase Tipo de empleo : Tiempo completo
icon geo-alt Sant Cugat Del Vallès, Catalonia

Descripción del trabajo - Regulatory Affairs Technician

  • Studying scientific and legal documents
  • 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*


AB-Biotics, S.A. utiliza JOIN para gestionar las solicitudes de esta oferta. Tu información será remitida al reclutador a través de JOIN, dónde puedes revisar el estado de tu solicitud en cualquier momento. Al clicar e "Solicite ya" , aceptas los términos y condiciones y política de privacidad de JOIN.
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