Job Description
Regulatory Operations Officer
The Regulatory Operations Officer will drive regulatory submission creation and management for UK, EU and Rest of the World markets. If you are keen to join a patient centric, high-growth company, then read on and apply today!
What You Will Do
1. Work closely with regulatory strategy team to prepare applications for submission in EU, CH, UK, FSA, MENA, LATAM and APAC territories.
2. Compile, publish, validate and dispatch regulatory dossiers (eCTD, NeeS, paper submissions) in line with regional/local requirements.
3. Resolve technical validation issues with Competent Authorities
4. Use internal electronic systems for planning, preparing, tracking and storing submissions to Competent Authorities. Perform technical quality checks on submission output to ensure compliance with Competent Authority requirements.
5. Participate in Regulatory Information Management System Project to enhance internal system
6. Collaborate with IT to troubleshoot and streamline publishing processes. Provide troubleshooting support for eCTD compilation and validation issues.
7. Archive agency correspondence in a timely manner. Ensure archived submissions and records are compliant with internal quality standards and inspection ready.
8. Ensure all approved SmPC and PIL are uploade...