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.
- 25 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.
