Description
Syneos Health is seeking a Senior Clinical Trial Regulatory Advisor. As a regulatory delivery professional, you will be responsible for converting regulatory strategy into accurate, timely, and compliant execution.
Primary Outcomes:
- Submission readiness and quality
- Accurate regulatory plans and assumptions
- Timely document collection and review
- Early identification of regulatory constraints
- Clear integration with the study activation plan
- Compliance with applicable requirements
Required Capabilities:
- Regulatory submission execution
- Country and regional requirement knowledge
- Planning and document management
- Quality and compliance discipline
- Risk identification
- Clear cross-functional communication
- Data and milestone accuracy
Required Experience:
- Preparation, coordination, or oversight of clinical-trial submissions
- Work across multiple countries or submission pathways
- Management of submission documentation and dependencies
- Interaction with study teams, sites, and regulatory stakeholders
- Resolution of submission-readiness or quality issues