Regulatory Affairs Specialist

Location: Ljubljana, Slovenia

About the Role

At 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 Responsibilities

• Support the Linguistic Review process for centrally approved products in line with AstraZeneca procedures and external regulations

• Prepare and submit lifecycle maintenance submissions in National, MRP and DCP procedures to JAZMP within agreed deadlines

• Contribute local documentation to the Enterprise Regulatory Vault in accordance with AstraZeneca procedures and external requirements

• Communicate Slovenian Health Authority outcomes, including commitments and registration status parameters

• Maintain accurate and timely updates in the CONSTELLATION regulatory submission tracking system

• Keep the Enterprise Regulatory Vault and local SharePoint site updated with the latest approved Market Product Information documents

• Support 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 SOPs

• Act as MC Regulatory Approver and Reviewer in NG Gazelle as per GLBP SOP, and as MC Regulatory Initiator when required

• Create and submit LRFs in Gazelle for all MRP, DCP and NP submissions

• Perform linguistic and quality checks of packaging materials, including cartons and leaflets

• Identify and report regulatory issues in the VQV system and escalate regulatory risks to the Regulatory Affairs Manager

• Update the EUCAN Launch Tracker with regulatory information from monthly reports

• Engage cross-functionally with Medical Affairs, Patient Safety, labelling and submission management teams to support shared objectives

• Ensure compliance with local legislation, the AZ Code of Ethics, the AZ Slovenia Pharma Code and all relevant internal policies and training requirements

Key Performance Areas

• Accuracy and completeness of regulatory submissions and documentation

• Timely delivery of submissions, labelling activities and system updates

• Reliable maintenance of regulatory tracking systems and product information records

• Effective collaboration with local, cluster and global stakeholders

• Compliance with external regulations and AstraZeneca policies

Your Profile

• University degree in Pharmacy, Medicine, Veterinary Medicine, Biology, Chemistry or another equivalent scientific field

• Open to candidates at the start of their career, including recent graduates with relevant internship experience; initial experience in regulatory affairs is an advantage

• Fluent Slovenian and excellent English, written and spoken

• Strong attention to detail and the ability to work with regulatory and legislative texts

• Strong computer skills and confidence working with digital systems

• Proactive and communicative, comfortable voicing ideas and asking questions

• Knowledge of the drug development process, product life-cycle and the content and formatting of regulatory submissions is desirable

• Knowledge of EU authorisation procedures and post-market requirements is desirable

Why Join Us?

• Develop expertise in a specialist field at the centre of how our medicines reach patients

• Gain early insight into our pipeline and new developments across therapeutic areas

• Collaborate with global functions across the EUCAN community and with colleagues across the Balkan cluster

• Build your career in an environment that values accuracy, curiosity and continuous learning

• Join a global, research-driven organisation at a time of significant change in European pharmaceutical legislation and digital ways of working

Ready to make a difference? Apply today and join us!

Date Posted

Closing Date

AstraZeneca 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.