Ranjith Kumar Chapala
Pharmaceutical / Bio-tech
Services offered
Enthusiastic Pharmaceutical Professional with over 5 years of prodigious experience in the clinical research. eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of clinical research and Regulatory aspects.
Experience
I have extensive experience in clinical research and regulatory affairs, managing all phases of clinical trials from start-up to closeout in alignment with ICH-GCP, FDA, and IRB guidelines. My roles have included overseeing regulatory submissions, document management, and Trial Master File (TMF) maintenance to ensure inspection readiness. Skilled in coordinating with cross-functional teams, I support the development of study protocols, informed consent forms, and other regulatory documents, and have expertise in patient recruitment, data collection, and protocol compliance. With a strong background in oncology, rheumatology, and infectious diseases, I am dedicated to advancing clinical trial efficiency and regulatory compliance across diverse therapeutic areas.
Education
- Master in Regulatory Affairs - Northeastern University (GPA 3.9/4.0) Boston, MA
- Doctor of Pharmacy - Mallareddy University (GPA 3.7/4.0) Hyderabad, IN
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