Fortrea is seeking a Site Readiness and Regulatory Specialist I to join our dynamic team in Mumbai, Bangalore, or Pune. This role is crucial in ensuring compliance with regulatory requirements for clinical trials under European Clinical Trials Regulation No 536/2014.

Job Overview

Job Summary: This entry-level role offers the opportunity to support global clinical trial operations by ensuring that all documentation and regulatory processes are completed accurately and in compliance with CTIS and European regulations.

Company Profile: Fortrea is a leading global contract research organization (CRO) dedicated to advancing healthcare through innovative clinical trials and regulatory solutions. We partner with pharmaceutical, biotechnology, and medical device companies to accelerate drug development and ensure compliance with global regulations.

Key Responsibilities

• Develop awareness of regulatory requirements with guidance from senior staff.
• Assist in compiling Part I application details in the Clinical Trial Information System (CTIS).
• Upload required documents to CTIS accurately and on time.
• Coordinate submission fees and obtain approvals from GRSL.
• Monitor CTIS for updates and relay alerts promptly to the GRSL.
• Maintain submission records and update tracking systems.
• Upload final documents to TMF and conduct reviews.
• Perform QC on applications and submit them post-approval.
• Ensure documentation is audit-ready at all times.
• Participate in internal meetings and escalate issues as needed.

Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
• Experience in regulatory affairs or clinical research is preferred.
• Familiarity with CTIS and EU Clinical Trials Regulation is an advantage.
• Strong documentation and organizational skills.
• Proficiency with document tracking tools and systems.
• Ability to work effectively under supervision and in global teams.

Why Join Fortrea?

• Contribute to high-impact global clinical research projects.
• Collaborative and inclusive workplace culture.
• Opportunities for professional development and upskilling.
• Work/life balance and healthcare benefits.

How to Apply

Visit the provided application link and submit your details to apply.

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