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You will be updated with latest job alerts via emailActs as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex
• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
• Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
• Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff
• May strategically plan and perform European centralized submissions and facilitate global submissions
• May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
• Deliver regulatory training/presentations as required.
• May perform additional tasks as deemed appropriate by Line Manager
Full-time