Regulatory Affairs Specialist
Core
Support quality review and timely submission of regulatory documentation for the Slovenian market, including lifecycle maintenance submissions and labelling processes within European regulatory procedures.
Role type
Regulatory Affairs Specialist (National Market)
Builds
Regulatory submissions, approved Market Product Information documents, and compliant packaging artwork for the Slovenian market.
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission preparation, linguistic review, compliance with local/EU legislation, system data entry, cross-functional collaboration, risk identification and escalation
Preferred skills
Drug development process knowledge, EU authorisation procedures, post-market requirements
Technologies
CONSTELLATION, Enterprise Regulatory Vault, SharePoint, NG Gazelle, VQV, AstraZeneca Global Labelling system
Responsibilities
Prepare and submit lifecycle maintenance submissions (MRP, DCP) to JAZMP; perform linguistic and quality checks of packaging materials; create and submit LRFs in Gazelle; update regulatory tracking systems and product information records; communicate Health Authority outcomes; act as MC Regulatory Approver/Reviewer/Initiator
Seniority
Entry-level / Junior