Regulatory Specialist

Role : Regulatory Specialist

Location : Chennai, Tamil Nadu

Experience : 7+ Years

Job Requirements :

• Bachelor’s degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a
• related field.
• 2–5 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.