Responsible for performing, reviewing and approving local regulatory affairs activities, with especial focus in the Spain registration process for allergen medicines (Orden Ministerial SND/778/2023).Client DetailsInternational Pharmaceutical CompanyDescriptionEnsure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.Work with internal & external customers to provide data and accurate regulatory input.Prepare & review labelling/Packaging texts and information brochures and communication activities.Run regulatory local projects meeting timelines and costsUnderstand relevant legislative and regulatory guidance applicable to activitiesPrepare risk benefit analysisActive involvement in concepts of regulatory strategyAttend industry and RA meetingsCommunicating with local regulatory agencies and document communicationProvide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing depts.Prepare and update local SOPsTo comply with all Good Regulatory Practices, refer to formalized, mandatory policies that define common and transparent rules for regulatory agencies.To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and Others.To control and maintain your personal training folder.To comply with all Company policies and procedures.To follow a code of conduct conducive to a professional environmentProfileLife sciences degree related to the activity Minimum of 8 years in the regulatory pharmaceutical field (preferred experience with biological products)Demonstrated ability to write good quality documentsHighly PC literateProject management abilitiesBreadth of technical regulatory knowledge & regulatory procedures in a variety of marketsFluency in English languageJob OfferFlexible hybrid modelFlexible shiftBarcelona based1 year contract#J-18808-Ljbffr