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.
Key Responsibilities:
- Develop awareness of regulatory legislation, guidance, and practices in assigned regions/countries with support from senior staff.
- Assist in completing Part I application information in the Clinical Trial Information System (CTIS) under supervision.
- 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 any updates.
- Track all submissions and approvals in designated tracking tools.
- Upload final submission packages to the Trial Master File (TMF) and perform functional reviews.
- Conduct quality checks (QC) on Part II applications as delegated.
- Submit applications/notifications in CTIS upon GRSL approval.
- Maintain high-quality documentation and ensure systems are audit-ready at all times.
- Escalate study-related issues in a timely manner.
- Attend team and company meetings as required.
- Perform additional duties as assigned by management.
Qualifications & Skills:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Prior experience in regulatory affairs, clinical research, or site readiness is a plus.
- Familiarity with European Clinical Trials Regulation (No 536/2014) and CTIS is advantageous.
- Strong attention to detail and organizational skills.
- Ability to work under supervision and collaborate with global teams.
- Proficiency in document management systems and regulatory tracking tools.
About Fortrea
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.
At Fortrea, we foster a collaborative and inclusive work environment, offering employees opportunities for professional growth and development. Our commitment to quality, integrity, and patient safety makes us a trusted name in the clinical research industry.
How to Apply
