Ekagra Sinha
Regulatory Specialist in GSK; Pharmaceutical Regulatory affairs at Manipal College of Pharmaceutical Sciences
- Role
- Regulatory Submission and Business Performance Lead at GSK
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ekagra Sinha
Experienced pharmaceutical professional with expertise in regulatory affairs, clinical trials, and quality control. I am an accomplished pharmaceutical professional with a strong background in regulatory affairs, clinical trials, and quality control. With a diverse range of experiences in both industry and hospital settings, I bring a comprehensive understanding of the pharmaceutical landscape.In my recent role as an intern at GSK Global Capability Center (GCC), I successfully completed submissions using Veeva Vault software and managed multiple submissions involving various stakeholders. I handled complex submission processes on IRAS and Eudralink portals for MHRA, UK, and ANSM, France.During my industrial training at Alkem Laboratories Limited R&D Center, I gained valuable experience in formulation development and quality control. Working with advanced equipment such as Fluidized Bed Dryer and Granulator, I developed a deep understanding of granulation processes. I also conducted pre-formulation studies, accelerated stability studies, and worked with quality control equipment like HPLC and LC-MS.My hospital pharmacy internship at KMC Manipal provided comprehensive knowledge of dispensing practices for in-patients and out-patients. Managing supply chain activities and accurately fulfilling demands from the wards contributed to effective patient treatments.In addition to my professional experiences, I have conducted research projects on FDA warning letters for scientific investigations and completed a thesis on the approval of novel excipients in the USA and Europe. My academic achievements include being a gold medalist in M. Pharm Pharmaceutical Regulatory Affairs and achieving All India Rank 10 in Manipal Entrance Test (MET) PG 2021. I have received recognition for stakeholder management and TMF filling. I also won an idea competition, securing funding for my innovative concept,\'Drink in Peace\'- an Anti-Hangover Drink.Outside of my professional accomplishments, I have actively participated in extracurricular activities, serving in leadership roles within Rotaract Club of MAHE and contributing to the BD-PR department of Manipal Digest.With a strong passion for the pharmaceutical industry, I am eager to contribute my expertise and join a dynamic organization that values innovation, compliance, and excellence. Let\'s connect to explore potential collaborations or opportunities within the pharmaceutical sector.
Experience
Regulatory Submission and Business Performance Lead
Jan 2026 — Present · Mumbai, IN
Education
Lilavatibai Podar Sr Secondary School
10+2, Science and Mathematics
Manipal Academy of Higher Education
Master of Pharmacy MPharm, Pharmaceutical Regulatory Affairs
Manipal Academy of Higher Education
Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration
2017 — 2021
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