At KRKA Spain, a member multinational pharmaceutical company, present in over 70 countries and leader in the production and distribution of medicines, we are looking for aRegulatory Associateto join our team.Key Responsibilities:Monitoring and managing product registration regulationsPreparing regulatory activity plans for individual productsPreparing, in cooperation with expert departments at Krka, the registration documentation and translations into local languageSubmitting registration documentation to the relevant state institutions in order to be granted marketing authorisation as soon as possibleConducting registration procedure – supporting the procedure during all phasesProviding on-going information about problems in obtaining marketing authorisation (in writing)Participating in the organisation and/or realisation of document and text translations into local languageChecking and making corrections of packaging materials written in local language intended for submission to regulatory authorities and before final printOrganising, providing guidance and keeping records on receipt, distribution and archiving of internal and external documentation,



information and dataKeeping the data base and documentary records on the registration procedures and distributing relevant data concerning the marketing authorisationsSetting up and maintaining the information system for the entire product range in the territoryMonitoring, analysing and assessing work resultsSubmitting the pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilanceConducting tasks in compliance with rules from the fields of quality assurance, occupational health and safety, and fire safetyAll other tasks assigned by superiors and consistent with employee’s qualifications and needs of the work processWhat we expect from candidates:Education: University degree in Pharmaceutical Sciences or life sciencesExperience: minimum 1 year experience in registrationsLanguages: fluent English (independent user level)Good organizational and planning skillsAttention to detail and ability to meet predefined deadlinesAdaptability to change#J-18808-Ljbffr

📌 Regulatory Affairs Associate (Madrid)
🏢 Krka
📍 Madrid