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Site Readiness and Reg Specialist I

Fortrea

2 - 5 years

Mumbai

Posted: 31/05/2025

Job Description

Develops awareness of regulatory legislation, guidance, and practice in the assigned regions/countries with the support from senior staff Completes the following activities for clinical trial applications performed according to European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS) under supervision and in close collaboration with the Global Regulatory Submissions Lead (GRSL) colleagues: Completes Part I application information in Clinical Trial Information System (CTIS) Accurately uploads all Part I and Part II documents to CTIS Initiates the payment process for Part I and/or Part II submission fees and seeks approval from GRSL Monitors CTIS and promptly informs the GRSL of all received alerts in CTIS Ensures timely tracking of all submissions and approvals (decisions) in applicable tracking tools Uploads the final submitted package to the Trial Master File and performs functional reviews as applicable Performs a review of final submission documents as applicable and specifically performs QC of Part II applications (as delegated) Submits application/notifications in CTIS upon permission of GRSL Ensures high quality documents are uploaded and filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time Escalates study issues appropriately and in a timely fashion Attends team and company meetings as applicable Performs other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)

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About Company

Fortrea is a leading global Contract Research Organization (CRO) that provides comprehensive clinical development and consulting services to pharmaceutical, biotechnology, and medical device companies. Spun off from Labcorp in 2023, Fortrea specializes in managing clinical trials from early-phase research to late-stage development. With a global footprint, the company supports the development of new therapies by offering services in clinical trial management, regulatory consulting, data management, and more. Its mission is to help bring innovative, life-saving treatments to market faster and more efficiently.

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