Regulatory Specialist

Role: Regulatory SpecialistLocation: Chennai, Tamil NaduExperience: 6+ YearsJob Requirements:- Bachelor’s 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.

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