Site Readiness and Regulatory Expert

1 day ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 15,00,000

Job Title: Site Readiness and Regulatory Specialist

Mumbai, Maharashtra, India, On-site job.

We are seeking a motivated problem-solver to join our team. As a Site Readiness and Regulatory Specialist, you will develop awareness of regulatory legislation, guidance, and practice in the assigned regions and countries with the support from senior staff.

Main Responsibilities:

  • Complete Part I application information in Clinical Trial Information System (CTIS) under supervision and in close collaboration with Global Regulatory Submissions Lead (GRSL) colleagues.
  • Accurately upload all Part I and Part II documents to CTIS.
  • Initiate the payment process for Part I and or Part II submission fees and seek approval from GRSL.
  • Monitor CTIS and promptly inform the GRSL of all received alerts in CTIS.
  • Ensure timely tracking of all submissions and approvals decisions in applicable tracking tools.
  • Upload the final submitted package to the Trial Master File and perform functional reviews as applicable.
  • Perform a review of final submission documents as applicable and specifically perform QC of Part II applications as delegated.
  • Submit application notifications in CTIS upon permission of GRSL.

Qualifications:

  • Develops awareness of regulatory legislation, guidance, and practice in the assigned regions and countries.
  • Completes 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.

Benefits:

  • Promote the swift delivery of life-changing ideas and therapies to patients in need.
  • Join an exceptional team where personal growth is nurtured enabling you to make a meaningful global impact.
  • Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Keywords: Site Readiness Regulatory Specialist.



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