Clinical Trial Regulatory Specialist (Serbia)

About the role

Syneos Health, a fully integrated life sciences services organization, is hiring a Clinical Trial Regulatory Specialist based in Serbia (Belgrade, hybrid). The specialist works within the CTRA team, delivering regulatory expertise on core submissions and supporting clients from site startup until study end.

Key responsibilities

• Prepare technical components of regulatory core submissions such as EU Clinical Trial Regulation Part I and/or II
• Compile and perform regulatory core submissions under supervision, and handle non-complex submissions independently
• Support agency interactions and conduct quality control reviews of documents, tracking them until final submission or delivery to the client
• Attend client meetings as needed and build client relationships
• Identify and report on process and risk areas, and ensure compliance with quality standards
• Maintain knowledge of applicable regulations and guidance on pre- and post-market requirements for healthcare products
• Perform other duties assigned by management in line with corporate policies and SOPs, and travel approximately 10% of the time

Required profile

• Minimum of a BA or BS degree (preferred)
• Experience working to GxPs such as GVP, GCP and ISO 14155
• Excellent written and oral presentation, documentation, influencing and interpersonal skills, with a team-oriented approach

Required skills

• Proficiency in Microsoft Office Suite
• Web-based systems, voicemail, email and internet