Description
We are seeking an Associate Director of Clinical Trial Regulatory Affairs to join our team on a remote or hybrid basis in Serbia.
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
Additional Requirements:
- Fluency in English is essential.
- Expertise in IVD/CDx strategy and submissions under the IVDR.
About Syneos Health: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.