Role : Regulatory Specialist

Location : Chennai, Tamil Nadu

Experience : 6+ Years

Job Requirements:

Bachelors degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field.
6+ years of regulatory experience in clinical research or pharmaceutical environments.
CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided.
Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance.
Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation.
Experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) platforms, and eISF systems.
Working knowledge of FDA, OHRP, and ICH-GCP guidelines.
Prior experience supporting sponsor or FDA audits/inspections.
Strong organizational, communication, and time-management skills.
Ability to work independently and manage multiple priorities.

Regulatory Specialist