Job Summary
Fortrea is seeking a Site Readiness and Regulatory Specialist I for its Clinical division across multiple locations. This entry-level regulatory role involves handling submissions via the Clinical Trials Information System (CTIS), ensuring adherence to European Clinical Trials Regulation No 536/2014. The position requires meticulous documentation, cross-functional coordination, and quality control to support successful clinical trial applications globally. This is an On-site opportunity providing valuable experience in global regulatory operations within the pharmaceutical and healthcare research industry.
Key Responsibilities
Develop understanding of regulatory legislation and practices in assigned regions with guidance from senior staff.
Complete Part I and II applications in CTIS under supervision.
Upload accurate and complete submission documents to CTIS.
Initiate and process submission fees in coordination with the Global Regulatory Submissions Lead (GRSL).
Monitor CTIS alerts and promptly update the GRSL team.
Track submissions and approvals in internal systems.
Upload finalized documents to the Trial Master File and perform functional reviews as assigned.
Conduct quality control checks of Part II applications as delegated.
Submit applications/notifications in CTIS with GRSL’s permission.
Maintain audit-readiness by ensuring system updates and document filing are completed on time.
Escalate study issues appropriately and promptly.
Participate in team and company meetings as required.
Perform additional duties as per country-specific or situational needs under supervision.
Required Skills & Qualifications
Basic awareness of clinical trial regulatory requirements and guidelines.
Familiarity with CTIS and the European Clinical Trials Regulation No 536/2014 preferred.
Strong attention to detail and document management skills.
Good communication and organizational abilities.
Ability to work in a cross-functional team with guidance from senior colleagues.
Proficiency in Microsoft Office tools and clinical document systems (e.g., Trial Master File systems).
Perks & Benefits
Opportunity to work with a globally recognized CRO.
Gain hands-on experience in global clinical trial regulations.
Collaborative and learning-focused work environment.
Exposure to cutting-edge clinical research processes.
Company Description
Fortrea is a leading global Contract Research Organization (CRO) delivering expert clinical development and technology solutions across 20+ therapeutic areas. With operations in approximately 100 countries, Fortrea supports pharmaceutical, biotechnology, and medical device companies in advancing healthcare innovations worldwide.
Work Mode
On-site – Multiple Locations
Call-to-Action
If you are detail-oriented and passionate about starting or advancing your career in clinical trial regulatory affairs, apply now to join Fortrea’s global clinical operations team and help shape the future of healthcare research.
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Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Croatia |Zagreb :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
Prague |Chile :
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