About this opportunity
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
15-Sep.-2026
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.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 407 comparable Regulatory Affairs roles across 100 biopharma companies.
Salary context
116 of 407 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 407 comparable roles
+ 36 more countries
Seniority mix
332 of 407 peers have a known seniority level
Therapeutic area mix
38 of 407 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Open in 3 locations
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.