Regulatory Compliance Specialist (Remote, Serbia)

About the role

Worldwide Clinical Trials, a global CRO, is hiring a Specialist, Regulatory Compliance for a remote position open to candidates based in Serbia. The role ensures that essential study documentation is reviewed, approved and maintained to high quality before study sites are activated, supporting timely study start-up and compliance with regulations, industry standards and internal procedures. You will work with cross-functional teams and stakeholders across time zones.

Key responsibilities

• Lead regulatory compliance activities for assigned projects and act as the primary Regulatory Compliance representative in global project teams.
• Develop and maintain Essential Document Review Plans, review requirements, country-specific checklists and project templates.
• Review, assess and approve essential document packages against regulations, SOPs, guidelines and project requirements.
• Partner with Site Activation, Regulatory Affairs, Site Contracts, Project Leadership and sponsors to prioritise document reviews and synchronised start-up timelines.
• Identify documentation gaps, communicate corrective actions and drive timely resolution before approval.
• Maintain project tracking tools to show review progress and approval status.
• Prepare and submit approved documents for Trial Master File filing, as applicable.
• Support training and guidance for sponsor and CRO personnel on document collection, maintenance and compliance.
• Escalate quality concerns and contribute to continuous compliance and quality oversight.

Required profile

• University degree preferred, ideally in a Life Science discipline, with at least 3 years of relevant experience including 1 year in a similar role; or an equivalent combination of education and experience (4 years in comparable positions and 2 years in a similar role).
• Knowledge of ICH, GCP, FDA and/or EU regulatory requirements and applicable local regulations.
• Experience reviewing, managing and maintaining essential study documentation and regulatory compliance processes.
• Strong organisational, planning, scheduling and time management skills, with good problem-solving and communication skills.
• Proficiency in written and spoken English.

Required skills

• Microsoft Office (Word, Excel, PowerPoint)
• Electronic document management systems