Life Sciences Jobs at Fortrea – Apply Now!
Are you a regulatory professional passionate about clinical trial documentation and compliance? Fortrea is hiring a Site Readiness and Regulatory Specialist I in Bangalore. This role offers a fantastic opportunity to support EU Clinical Trials Information System (CTIS) submissions and work closely with global regulatory teams. If you have 2–5 years of relevant experience and a life sciences background, apply today to become part of a leading force in clinical development.
- Job Position: Site Readiness and Reg Specialist I
- Location: Bangalore
- Job Requisition ID: 2443456
About The Company
Welcome to Fortrea, a leading company that promotes innovation in the life sciences industry. At Fortrea, we value excellence, teamwork, and commitment to regulatory compliance. We are currently seeking a diligent and detail-oriented individual to join our team in Bangalore as a Site Readiness and Regulatory Specialist I.
This role involves developing awareness of regulatory legislation, guidance, and practice in the assigned regions/countries with the support of senior staff.
Life Sciences Job at Fortrea- Job Summary:
Fortrea seeks a Site Readiness and Regulatory Specialist I to support regulatory submissions and clinical trial documentation following EU Clinical Trials Regulation (CTR) No. 536/2014. This role is integral in managing Clinical Trials Information System (CTIS) processes and ensuring regulatory compliance in collaboration with Global Regulatory Submissions Lead (GRSL) colleagues.
Life Sciences Job at Fortrea – Key Responsibilities:
- Prepare and complete Part I application data in CTIS under supervision.
- Accurately upload all required Part I and II documents into CTIS.
- Initiate and track payment processes for submissions and obtain GRSL approvals.
- Monitor CTIS alerts and escalate to GRSL as needed.
- Maintain timely and accurate updates in internal tracking tools and systems.
- Upload final submission documents to the Trial Master File (TMF).
- Perform quality control checks for Part II submissions, as delegated.
- Submit notifications in CTIS upon GRSL approval.
- Ensure all documents meet audit readiness standards.
- Attend internal team and company meetings.
- Perform other duties as required by the country/regional needs under supervision.
Life Sciences Job at Fortrea – Requirements:
- 2–5 years of relevant experience in EU CTR and CTIS submissions.
- Graduation or Master’s degree in Life Sciences.
- Strong understanding of regulatory compliance in clinical research.
- Attention to detail and the ability to work collaboratively in a global team.
Keywords: Fortrea, Site Readiness, Reg Specialist, Job Opportunity, CTIS submissions, Bangalore, regulatory compliance
