Regulatory Affairs Specialist
On-siteZagreb, Zagreb, Croatia
Job Summary
Prepare and manage regulatory submissions for National, MRP, and DCP procedures while coordinating linguistic reviews for centrally approved products. Contribute local documentation for ERV regulatory submissions and maintain regulatory databases, ERV records, and local SharePoint documentation with the latest approved product information. Serve as an MC Regulatory Approver and Reviewer within the NG Gazelle labelling system and act as Regulatory Initiator when required. Coordinate the creation and maintenance of Croatian-language market-specific and shared-pack labelling through AstraZeneca's global systems and collaborate with Logistics teams on implementation plans. Act as the local administrator for the EUCAN Launch Tracker, managing user access and supporting training activities. Support Good Regulatory Practice (GRP) activities, including Enterprise Quality Vault updates and maintenance of local procedural documentation.
Required Qualifications
- Degree in Life Sciences, Pharmacy, or another relevant scientific discipline, or statutory qualifications required within the local market
- Experience working within Regulatory Affairs in the pharmaceutical industry
- Knowledge of EU regulatory requirements and pharmacovigilance regulations
- Strong verbal and written communication skills
- Excellent command of English
- Digital and AI literacy
- Experience using regulatory systems and processes
- Strong attention to detail with a focus on quality, accuracy, and compliance
Desired Qualifications
- Knowledge of drug development, product lifecycle management, and regulatory submission requirements
- Understanding of EU marketing authorisation procedures and post-approval regulatory activities
- Experience working with labelling systems and regulatory databases
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