Clinical Trials Regulatory Job at Fortrea

Clinical Trials Regulatory Job at Fortrea – Apply by July 31, 2025

📍 Location: Bangalore, India
🕒 Job Type: Full-time
🆔 Requisition ID: 2443456
📅 Application Deadline: July 31, 2025 (30+ days left!)

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🌐 About Fortrea

Fortrea is a leading global contract research organization (CRO) committed to advancing healthcare through innovative clinical trials and regulatory solutions. With a strong presence in Bangalore and worldwide, Fortrea supports pharmaceutical, biotechnology, and medical device companies in bringing life-changing therapies to market.

Join our dynamic team and contribute to groundbreaking clinical research while enhancing your expertise in regulatory submissions and compliance.

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💼 Job Title: Site Readiness and Regulatory Specialist I

🔍 Key Responsibilities:

• Support compliance with European Clinical Trials Regulation No 536/2014.
• Enter Part I application data into CTIS under supervision.
• Upload Part I and Part II documents accurately into CTIS.
• Initiate payment processes for submission fees and obtain GRSL approval.
• Monitor CTIS alerts and report to GRSL.
• Track submissions and approvals in tracking tools.
• Upload final packages to the Trial Master File (TMF).
• Perform functional reviews and conduct QC checks on delegated tasks.
• Submit applications/notifications in CTIS after approval.
• Maintain high-quality documentation and audit-readiness.
• Escalate study issues as needed and attend team meetings.

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🎓 Experience & Qualifications:

• 2–5 years of experience in EU CTR and CTIS submissions.
• Bachelor’s or Master’s degree in Life Sciences or a related field.
• Detail-oriented and compliance-driven mindset.
• Knowledge of regulatory guidelines and clinical trial documentation.

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⭐ Why Join Fortrea?

• Work with a globally respected CRO in the field of clinical research.
• Opportunities for career growth in regulatory affairs and compliance.
• Collaborative, expert-led work environment.
• Competitive salary and benefits aligned with industry standards.

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📩 How to Apply

If you meet the qualifications and are excited to contribute to clinical research, don’t wait!

🗓️ Last Date to Apply: July 31, 2025

🔗 Application Link: 

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