Regulatory Affairs Technician

hace 3 días

Sant Cugat, Barcelona, España AB-BIOTICS A tiempo completo

  • 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*

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