Specialist, Regulatory Compliance (Serbia)

A global role ensuring essential study documentation is reviewed, approved, and maintained to the highest quality standards before study sites are activated, supporting the timely start-up of clinical research studies and compliance with applicable regulations, industry standards, and internal procedures. This is a remote role open to candidates based in Serbia, collaborating with global teams across multiple time zones.

Responsibilities

Lead regulatory compliance activities for assigned projects and serve as the primary Regulatory Compliance representative within global project teams; Develop and maintain Essential Document Review Plans, review requirements, country-specific checklists, and project templates to support study start-up activities; Review, assess, and approve essential document packages to ensure compliance with applicable regulations, SOPs, guidelines, and project requirements; Partner with Site Activation, Regulatory Affairs, Site Contracts, Project Leadership, and sponsors to prioritize document reviews and support synchronized study start-up timelines; Identify documentation gaps, communicate corrective actions, and drive timely resolution of issues before document approval; Monitor and maintain project tracking tools to provide visibility into document review progress and approval status; Prepare and submit approved essential documents for Trial Master File filing, as applicable; Support training and guidance for sponsor and CRO personnel on essential document collection, maintenance, and compliance requirements; Escalate quality concerns promptly and contribute to continuous compliance and quality oversight across projects

Requirements

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 including 4 years in comparable positions and 2 years in a similar role; Knowledge of ICH, GCP, FDA and/or EU regulatory requirements, as well as applicable local regulations; Experience reviewing, managing, and maintaining essential study documentation and regulatory compliance processes; Strong organizational, planning, scheduling, and time management skills with the ability to manage multiple priorities in a fast-paced environment; Excellent problem-solving skills, sound judgment, and the ability to identify situations requiring escalation or supervisory input; Strong interpersonal and communication skills with the ability to present information clearly and concisely; Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, and experience working with electronic document management systems; Proficiency in written and spoken English