Job Title: Site Readiness and Regulatory Specialist I
Location: Bangalore, India
Job Type: Full-time
Posted Date: Today
Application Deadline: July 31, 2025 (30+ days left to apply)
Requisition ID: 2443456
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.
Job Description
Key Responsibilities:
As a Site Readiness and Regulatory Specialist I, you will play a crucial role in ensuring compliance with European Clinical Trials Regulation No 536/2014 by managing submissions in the Clinical Trials Information System (CTIS). Your responsibilities will include:
- Completing Part I application information in CTIS under supervision.
- Uploading Part I and Part II documents accurately into CTIS.
- Initiating the payment process for submission fees and obtaining approvals from the Global Regulatory Submissions Lead (GRSL).
- Monitoring CTIS alerts and promptly informing GRSL of updates.
- Tracking submissions and approvals in designated tracking tools.
- Uploading final submission packages to the Trial Master File (TMF) and performing functional reviews.
- Conducting quality checks (QC) on Part II applications as delegated.
- Submitting applications/notifications in CTIS upon GRSL approval.
- Ensuring high-quality documentation and system updates for audit readiness.
- Escalating study issues in a timely manner.
- Attending team meetings and performing additional duties as required.
Experience & Qualifications:
- 2-5 years of experience in EU CTR and CTIS submissions.
- Educational Background: Graduation/Master’s degree in Life Sciences or related field.
- Strong attention to detail and ability to work in a compliance-driven environment.
- Familiarity with regulatory guidelines and clinical trial documentation.
Why Join Fortrea?
- Work with a globally recognized CRO in clinical research.
- Career growth opportunities in regulatory affairs and compliance.
- Collaborative work culture with industry experts.
- Competitive salary and benefits in line with industry standards.
How to Apply
If you meet the qualifications and are excited about contributing to clinical research, apply now before the deadline:
📅 Last Date to Apply: July 31, 2025