Assistant, Regulatory Affairs – Europe

This is a fully remote position, open to applicants in Croatia.

📋 Description

• Support the coordination of the translation for regulatory correspondence and submission documents, including protocols, synopsis, informed consent forms (ICF), and labels.

• Organize and send out regulatory submissions, site contracts, and site documentation, ensuring to follow up for delivery confirmations, acquire and file acknowledgment receipts, and update pertinent tracking tools.

• Conduct administrative quality control of regulatory submissions, site documents, and site contracts to verify accuracy, completeness, and proper formatting.

• Collaborate with the Finance department to request fee payments to Regulatory Authorities. Diligently monitor the assigned Therapeutic mailbox and direct requests to the appropriate team members for timely response.

⛳️ Requirements

• A minimum of 2 years of office or business experience in a supportive role.

• Experience in the CRO or pharmaceutical industry is preferred.

• A Bachelor’s degree or equivalent is preferred.

• Proficiency in the local language; working knowledge of English is required.

🏝️ Benefits

• Health insurance coverage.

• Opportunities for professional development.