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Engaged Employer

Fortrea Development India Private Limited

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3.9

based on 677 Reviews

30 Fortrea Development India Private Limited Jobs

Site Readiness and Reg Specialist II

Fortrea

3.9

based on 677 Reviews

3-7 years

Mumbai, Pune, Bangalore / Bengaluru

1 vacancy

Site Readiness and Reg Specialist II

Fortrea Development India Private Limited

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Auditing Clinical Trials Management Information System Payment Processing

+ 2 more

Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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 CTISInitiates 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)