Fortrea is a leading global contract research organization (CRO) dedicated to providing comprehensive clinical development solutions to pharmaceutical, biotechnology, and medical device companies. With a commitment to advancing healthcare, Fortrea supports clinical trials worldwide, ensuring compliance with regulatory standards and accelerating the delivery of life-changing therapies.
Join a dynamic team where innovation, collaboration, and regulatory expertise drive success in clinical research.
Job Description
Key Responsibilities:
- Develop awareness of regulatory legislation, guidance, and practices in assigned regions/countries with support from senior staff.
- Assist in completing Clinical Trial Applications (CTAs) under European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS).
- Accurately upload Part I and Part II documents to CTIS.
- Initiate the payment process for submission fees and seek approval from the Global Regulatory Submissions Lead (GRSL).
- Monitor CTIS for alerts and promptly inform GRSL of updates.
- Track submissions and approvals in designated tracking tools.
- Ensure timely filing of final submission documents in the Trial Master File (TMF).
- Perform quality checks (QC) on Part II applications as delegated.
- Submit applications/notifications in CTIS upon GRSL approval.
- Maintain high-quality documentation and ensure audit readiness.
- Attend team and company meetings as required.
- Perform additional duties as assigned by management.
Qualifications & Skills:
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- Basic understanding of clinical trial regulations (EU CTR 536/2014 preferred).
- Strong attention to detail and organizational skills.
- Ability to work under supervision in a fast-paced environment.
- Proficiency in Microsoft Office and regulatory submission systems (CTIS experience is a plus).
