Lekhana Palakurthi
Regulatory Affairs Intern @Neutron Therapeutics Llc
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WORK HISTORY
Regulatory Affairs Intern @Neutron Therapeutics Llc
Danvers, MA, US
Supporting the preparation of a Breakthrough Therapy Designation (BTD) request for a novel BNCT device.• Conducting literature reviews and analysing clinical data to support regulatory claims.• Assisting in drafting IND documentation in alignment with FDA regulatory requirements.• Collaborating with cross-functional teams to ensure clarity, accuracy, and compliance in submissions.• Participating in internal quality reviews to meet industry and agency standards
EDUCATION
Northeastern University
Master's degree
GITAM Deemed University
Bachelors in Pharmacy
ABOUT LEKHANA PALAKURTHI
Recent Master’s graduate in Regulatory Affairs from Northeastern University with hands-on experience in FDA submissions, GMP compliance, eCTD, and quality systems. Contributed to a Breakthrough Device Designation (BDD) request as part of a capstone project. Strong academic foundation in drug, biologics, and medical device regulations and real-world exposure to IND dossiers, QMS, and CMC documentation. Actively seeking full-time or internship roles in Regulatory Affairs, Quality Assurance, or Clinical Regulatory Operations across the U.S.
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