Regulatory Document Specialist

Syneos Health

. Independently manage assigned document packages and workflows for timely submission-ready documentation .

Posted 10/21/2026full-timeBelgrade • SerbiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in document management processes, including eDMS workflows and compliance with regulatory standards. Proficient in providing training and support while ensuring timely submission of documentation in a clinical or pharmaceutical environment.

Highest-signal resume keywords

Document Management Best PracticesEDMS ExperienceRegulatory Submission ComplianceMicrosoft Office ProficiencyGood Clinical Practice (GCP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document PreparationTechnical Quality ReviewFormatting and Metadata ManagementWorkflow ManagementProcess Improvement

Soft Skills

Time ManagementAdaptabilityCommunicationProblem-SolvingCollaboration

Tools & Technologies

EDMSVeeva VaultMicrosoft WordAdobe AcrobatISI Toolbox

Industry Keywords

CROPharmaceuticalSOPsEHS RegulationsLegacy Document Management

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Independently manage assigned document packages and workflows for timely submission-ready documentation
Advise colleagues and stakeholders on document preparation, RFS standards, eDMS processes, and associated tools
Provide training, guidance, and day-to-day support to users, including CRO users
Ensure documents comply with SOPs, guidelines, and RFS technical standards
Identify risks, escalate issues, and support resolutions to maintain project timelines
Support process-improvement initiatives and project activities
Maintain and improve departmental processes, templates, and guidance documents
Manage eDMS binders and workflows for clinical and nonclinical document packages through approval
Ensure metadata, hyperlinks, appendices, and regulatory submission binders are completed on schedule
Evaluate and resolve formatting, metadata, workflow, and structural issues
Perform technical quality reviews and correct format or architecture errors
Support testing and implementation of upgraded eDMS and authoring tools
Identify, locate, organize, and reformat legacy documents for eDMS upload
Communicate final submitted and approved regulatory documents and collaborate to meet deadlines
Comply with EHS regulations, report risks or malfunctions, and participate in EHS activities

Requirements

What you’ll need

At least C1 English skills
2–5 years of experience as a Document Specialist within a CRO or pharmaceutical environment
Strong interest in leveraging and implementing new technical tools
Flexible and adaptable, with the ability to reprioritize and work effectively under pressure
Excellent time management skills, with the ability to forecast and manage workload effectively
Experience with eDMS, Microsoft Word, PDF tools, and hyperlinking tools such as ISI Toolbox
Solid understanding of document management best practices and Good Clinical Practice (GCP)
Experience with eDMS and authoring tools, ideally Veeva Vault
Proficiency in Microsoft Office applications (Word, PowerPoint, Excel) and Adobe Acrobat
Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related discipline
Candidates with an Associate degree may be considered with relevant experience
Fluent in English

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Mandatory EHS training