Harshita P
Regulatory Affairs MS Candidate | Pharm.D. | Clinical Research & Project Coordination Experience | Ex-Imaging Endpoint | Accomplished Clinical Pharmacist Intern | Seeking Regulatory Affairs/Clinical Operations Co-op
- Role
- Regulatory Affairs Intern at AION Biosystems
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Harshita P
Pharm.D. professional transitioning to Regulatory Affairs through Northeastern\'s MS program, blending clinical insights with regulatory expertise to excel in the pharmaceutical and medical device industries. Driven by the profound impact of breakthrough therapies on patient outcomes, my career includes roles as a Clinical Project Coordinator overseeing trials with meticulous regulatory adherence. My academic journey at Northeastern has equipped me with in-depth knowledge of navigating complex technical documents, including 510(k), IDE, PMA, IND, NDA, amendments, and supplements, ensuring alignment with rigorous regulatory standards. I am dedicated to delivering tangible results, approaching challenges with a steadfast commitment to organizational success. Actively pursuing ongoing professional development, I am driven to advance in the dynamic fields of regulatory affairs and Clinical Operations.
Experience
Regulatory Affairs Intern
Sep 2024 — Present · Lowell, MA, US
Worked on the preparation and submission of eSTAR Traditional 510(k) regulatory submissions, ensuring compliance with FDA and global regulatory requirements- Assisted in handling post-market complaints and ensuring timely and accurate reporting, including root cause analysis and corrective actions- Supported the preparation and review of Standard Operating Procedures (SOPs), contributing to compliance and consistency across regulatory processes.
Education
Jawaharlal Nehru Technological University
Doctor of Pharmacy
2015 — 2021
Northeastern University
Master's degree
2023
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