Compliance

• Support monitoring activities (data collection)
• Support monitoring CAPAs
• Support transfer of value reporting
• Manage annual FMV updates
• Preparation, communication and monitoring of Data Privacy Notice (DPN)
• Support compliance trainings (systems)
• Support with systems by being a super user (e.g. Veeva, SOOS)
• Supporting Compliance Director and Senior Compliance Manager with various tasks

Junior Compliance Specialist supporting the pharmaceutical compliance in CEE region

Junior Compliance Specialist, CEE

Junior Compliance Specialist supporting compliance activities in CEE countries at Sobi. Focused on monitoring and reporting in the pharmaceutical sector with opportunities for growth.

• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation.
• Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
• Review and provide linguistic input for local Product Information and Mock-ups.
• Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
• Involvement in project management of the network of local contact persons for Regulatory affairs.
• Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes.
• Propose marketing authorization strategies tailored to client needs.
• Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

Senior Specialist in Regulatory Registration and Compliance for PrimeVigilance

Senior Specialist, Regulatory Registration and Compliance

Senior Specialist in Regulatory Registration and Compliance managing marketing authorization submissions for PrimeVigilance. Collaborating with regulatory authorities and clients to ensure compliance and provide regulatory advice.

Compliance jobs in Croatia

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Junior Compliance Specialist, CEE

Senior Specialist, Regulatory Registration and Compliance