Sr/Regulatory Affairs Specialist - FSP - EMEA
Core
Review and approve country- and site-level essential regulatory documents for clinical trial site activation, ensuring completeness, accuracy, and quality against regulatory guidelines.
Role type
Regulatory Affairs Specialist (Clinical Trials)
Builds
Essential Document Compliance (EDC) review packs for study sites
Domain
Pharmaceutical/Biotech / Clinical Research Operations
Deliverable
client delivery
Required skills
Regulatory document review, Essential Document Compliance (EDC) checklist management, regulatory guideline interpretation, document quality assurance, revision tracking, SOP adherence
Preferred skills
Local language proficiency, independent judgment, multi-project planning
Technologies
Microsoft Word, Excel, PowerPoint, data tracking systems
Responsibilities
Review country essential documents for completeness and accuracy; Review site essential documents for completeness and accuracy; Notify EDP Submitter of review outcomes and requested revisions; Review revised packs to ensure deficiencies are resolved; Track EDP review details in data systems; Maintain knowledge of current regulatory guidelines and SOPs