Regulatory Compliance Specialist

🔥 2 hours ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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 for compliance with 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 for 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 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

🏖️ Benefits

• Equal employment opportunities • Diverse and inclusive work environment • Collaboration and creativity-focused culture • Remote work arrangement • No travel required