Regulatory Document Specialist, Sponsor Dedicated (Serbia)

About the role

Syneos Health is hiring a Regulatory Document Specialist, sponsor dedicated, based in Serbia. The specialist supports Regulatory and submission teams in preparing electronic regulatory submissions to health authorities worldwide, managing document deliverables and workflows so that documents are completed in a high-quality Ready for Submission (RFS) format within agreed timelines.

Key responsibilities

• Independently manage assigned document packages and workflows, and act as a resource for colleagues on RFS standards, eDMS processes and tools.
• Train and support users, including those in CROs, so documents follow SOPs and meet RFS requirements.
• Support process improvement, process templates and guidance documents, and gather user feedback.
• Manage binders in the eDMS for clinical and nonclinical functions, complete metadata, develop appendices, create hyperlinks and include documents in submission binders on time.
• Evaluate and resolve formatting, metadata, workflow and structural issues, perform technical quality reviews and correct errors flagged by Regulatory Publishing.
• Contribute to team meetings, support testing of the upgraded eDMS and authoring tool, and help locate and reformat legacy documents.
• Communicate the status of submitted and approved documents and share knowledge across teams.
• Comply with EHS regulations, report risks and take part in mandatory EHS training.

Required profile

• 2-5 years of experience as a Document Specialist in a CRO or pharmaceutical environment; experience in a pharmaceutical environment preferred.
• Bachelor's degree in Life Sciences, Medicine, Pharmacy or a related discipline; an Associate degree may be considered with relevant experience.
• Fluent English (C1 level essential).
• Good time management, flexibility under pressure and proactive risk identification.

Required skills

• eDMS and authoring tools, ideally Veeva Vault
• Microsoft Office (Word, PowerPoint, Excel) and Adobe Acrobat
• PDF tools and hyperlinking tools such as ISI Toolbox
• Document management best practices and Good Clinical Practice (GCP)
• Working knowledge of eCTD compliance