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

  1. Regulatory Submission and Business Performance Lead

    GSK

    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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Ekagra Sinha — Regulatory Submission and Business Performance Lead at GSK in Mumbai, MH, IN | Unifers