Regulatory Affairs Specialist

Regulatory Affairs SpecialistLocation: Ljubljana, SloveniaAbout the RoleAt AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, willing to collaborate, and curious about what science can do, then you're our kind of person.We are looking for a Regulatory Affairs Specialist to join our Regulatory team in Ljubljana. In this role you will support the quality review and timely submission of regulatory documentation for the Slovenian market, work within European regulatory procedures including those of the European Medicines Agency, contribute to labelling processes in our global systems, and work alongside local, cluster and global colleagues to ensure our medicines reach patients in full compliance with local and European requirements. This is a permanent, office-based position and an excellent opportunity to build a career in regulatory affairs within a global, research-driven organisation.Key ResponsibilitiesSupport the Linguistic Review process for centrally approved products in line with AstraZeneca procedures and external regulationsPrepare and submit lifecycle maintenance submissions in National, MRP and DCP procedures to JAZMP within agreed deadlinesContribute local documentation to the Enterprise Regulatory Vault in accordance with AstraZeneca procedures and external requirementsCommunicate Slovenian Health Authority outcomes, including commitments and registration status parametersMaintain accurate and timely updates in the CONSTELLATION regulatory submission tracking systemKeep the Enterprise Regulatory Vault and local SharePoint site updated with the latest approved Market Product Information documentsSupport the creation of artwork for Slovenian language market specific and shared packs in the AstraZeneca Global Labelling system in line with local legislation and AZ SOPsAct as MC Regulatory Approver and Reviewer in NG Gazelle as per GLBP SOP, and as MC Regulatory Initiator when requiredCreate and submit LRFs in Gazelle for all MRP, DCP and NP submissionsPerform linguistic and quality checks of packaging materials, including cartons and leafletsIdentify and report regulatory issues in the VQV system and escalate regulatory risks to the Regulatory Affairs ManagerUpdate the EUCAN Launch Tracker with regulatory information from monthly reportsEngage cross-functionally with Medical Affairs, Patient Safety, labelling and submission management teams to support shared objectivesEnsure compliance with local legislation, the AZ Code of Ethics, the AZ Slovenia Pharma Code and all relevant internal policies and training requirementsKey Performance AreasAccuracy and completeness of regulatory submissions and documentationTimely delivery of submissions, labelling activities and system updatesReliable maintenance of regulatory tracking systems and product information recordsEffective collaboration with local, cluster and global stakeholdersCompliance with external regulations and AstraZeneca policiesYour ProfileUniversity degree in Pharmacy, Medicine, Veterinary Medicine, Biology, Chemistry or another equivalent scientific fieldOpen to candidates at the start of their career, including recent graduates with relevant internship experience; initial experience in regulatory affairs is an advantageFluent Slovenian and excellent English, written and spokenStrong attention to detail and the ability to work with regulatory and legislative textsStrong computer skills and confidence working with digital systemsProactive and communicative, comfortable voicing ideas and asking questionsKnowledge of the drug development process, product life-cycle and the content and formatting of regulatory submissions is desirableKnowledge of EU authorisation procedures and post-market requirements is desirableWhy Join Us?Develop expertise in a specialist field at the centre of how our medicines reach patientsGain early insight into our pipeline and new developments across therapeutic areasCollaborate with global functions across the EUCAN community and with colleagues across the Balkan clusterBuild your career in an environment that values accuracy, curiosity and continuous learningJoin a global, research-driven organisation at a time of significant change in European pharmaceutical legislation and digital ways of workingReady to make a difference? Apply today and join us!Date Posted15-Sep.-2026Closing DateAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.