Sreelakshmi Konakanchi
Regulatory Documentation Scientist @Kateric
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WORK HISTORY
Regulatory Documentation Scientist @Kateric
Bengaluru, IN
Write and review Phase CSRs, IBs, DSURs, PBRERs, CO, SCS, SCP, RMPs, and Briefing Packages in collaboration with Regulatory Project Managers, Clinical Science Leaders, and the International Project Team and in accordance with the Client Guidance Documents complying with the FDA/EMA regulatory guidelines.Authored and reviewed CTRs, protocols, and protocol annual updates submitted to ClinicalTrials.gov and European Clinical Trials Database (EudraCT). Experienced in handling the projects from kickoff to final submission to regulatory authorities.
EDUCATION
Jawaharlal Nehru Technological University
B. Pharmacy, Pharmaceutical Sciences
Institute of Clinical Research, India
M.Sc in Clinical Research, Clinical Research
Adarsha Junior college
Bi.PC, Biology, Physics, Chemistry
SKILLS
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