Podili Runesh
Regulatory Operations Assistant at Fortrea | NIPER-Guwahati alumni
- Role
- Regulatory Operations Assistant at Fortrea
- Location
- Vijayawada, IN
- LinkedIn followers
- 500 followers
About Podili Runesh
Enthusiastic Regulatory affairs professional with 3.1 years of expertise in CMC documentation, product lifecycle management, and global regulatory submissions. Experienced in coordinating change controls, managing specifications, supporting labelling projects, and ensuring compliance with international guidelines. Strong cross-functional collaboration and focus on quality, efficiency, and timely deliverables. Actively seeking new opportunities in Regulatory Affairs and Currently pursuing a flexible online MBA in Pharmaceutical Management to expand strategic and regulatory insight, I am eager to contribute to your team with a combination of regulatory expertise & strategic insight. Additionally, I have qualified for National-level examinations GPAT-2020 with All India Rank 446, NIPER-JEE 2020 with All India Rank 573.
Experience
Regulatory Operations Assistant
May 2022 — Present · Pune, IN
Responsible for creation/revision and compilation of specifications/documents/Global change controls for submission to US, EU, Japan, and ROW health authorities and oversight of the same.
Education
KVSR SIDDHARTHA COLLEGE OF PHARMACEUTICAL SCIENCES
Bachelor of Pharmacy - BPharm
2016 — 2020
National Institute of Pharmaceutical Education and Research (NIPER), Guwahati
Master of Science - MS
2020 — 2022
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