Regulatory Affairs Operation Specialist

Job Summary

Regulatory Affairs Operation Specialist. As part of the Regulatory Affairs team, the candidate will support the department in managing technical and regulatory data, ensuring accurate documentation and efficient back-office operations. This role contributes to maintaining regulatory databases, supports document workflows, and helps improve data-related processes in compliance with internal and external regulatory requirements.

Key Responsibilities

• Update ministerial and internal databases based on instructions from Regulatory Specialists.
• Collect, process, and archive technical data in both paper and electronic formats.
• Provide back-office support to the Regulatory team, including document management and data entry.
• Collaborate with cross-functional teams to ensure consistency and quality of regulatory data.
• Use ERP systems and company applications to manage and process technical data.
• Contribute to the continuous improvement of internal processes related to technical and regulatory data.

Requirements

• Bachelor's degree in a technical/scientific field (preferably Biology, Chemistry, Biomedical Engineering, or related).
• Intermediate IT skills; experience with ERP systems is a plus.
• Previous experience in data management or regulatory support roles is appreciated.
• Accuracy, methodical approach, and reliability.
• Analytical thinking and problem-solving skills.
• Strong interpersonal skills and team-oriented attitude.
• Good command of Italian and intermediate English (B1/B2).
• Familiarity with database management is a plus.
• Availability for short business trips to Switzerland (2-3 days per quarter) is required.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.