Rama Krishna Komiti

I’m a motivated and detail-oriented Clinical Research & Regulatory Affairs professional with hands-on experience in managing clinical trial documentation, regulatory submissions, and data coordination. My expertise includes working with CTIS, Veeva Vault, and electronic data capture (EDC) systems, along with a strong understanding of ICH-GCP guidelines and global regulatory requirements (EMA, USFDA).

I have contributed to the success of cross-functional clinical teams by ensuring accurate documentation, compliance, and effective communication between sites, sponsors, and regulatory authorities. Passionate about advancing clinical research, I thrive in roles where quality, collaboration, and patient safety are priorities.

I’m currently seeking opportunities in clinical operations, data management, or regulatory Affairs where I can contribute to impactful research and professional growth.

Regulatory and Clinical Research professional with hands-on experience in clinical trial documentation, regulatory submissions, and data management. Proven expertise in Clinical Trial Information System (CTIS), Veeva Vault, and Electronic Document Management Systems (EDMS), with exposure to EU-CTR processes, CTAs, and RFIs. Strong knowledge of ICH-GCP guidelines, GxP, and global regulatory frameworks (EMA, USFDA).

Skilled in coordinating cross-functional teams, maintaining audit-ready documentation, and ensuring protocol compliance throughout the clinical trial lifecycle. Adept in CRF handling, source data review, EDC systems, and regulatory milestone tracking. Known for attention to detail, excellent communication, and the ability to manage multiple projects efficiently in fast-paced, regulated environments.

Master of Pharmacy (M.Pharm)

Guru Nanak Institutions, Hyderabad

CGPA: 8.4/10

Bachelor of Pharmacy (B.Pharm)

Guru Nanak Institutions, Hyderabad

CGPA: 8.2/10

📜 Certifications

ICH–GCP (International Council for Harmonisation – Good Clinical Practice)

Clinical Research Certification