Aishwarya Shinde

Regulatory Specialist at Berjé | MS Regulatory Affairs, Northeastern University

Role
Regulatory Specialist at Berjé Inc
Location
Edison, NJ, US
LinkedIn followers
500 followers

About Aishwarya Shinde

As a highly skilled Regulatory Affairs professional with a robust background in pharmaceutical and medical device compliance, I bring extensive expertise in navigating complex global regulatory landscapes. With a Master of Science in Regulatory Affairs from Northeastern University and a proven track record across multiple organizations including Strive Pharmaceuticals, Becton, Dickinson and Company, and Massachusetts Department of Public Health, I have demonstrated exceptional capabilities in driving regulatory strategies, ensuring compliance, and optimizing operational efficiency.My professional journey has been characterized by a meticulous approach to regulatory challenges, with demonstrated success in areas such as comprehensive label review, cybersecurity guideline research, regulatory submissions, and cross-functional collaboration. I am highly proficient in global regulatory standards including US FDA, EU MDR, ISO certifications, and have expertise across diverse domains like device compliance, drug safety, technical writing, and pharmacovigilance. I am on the lookout for opportunities where I can leverage my regulatory expertise to foster innovation and ensure the safety and efficacy of biopharmaceuticals and medical devices. My goal is to contribute to the advancement of healthcare technologies, ensuring they meet stringent regulatory standards and ultimately improve patient outcomes. I am eager to work with organizations dedicated to advancing healthcare technologies, applying my knowledge to navigate global regulatory landscapes and bring groundbreaking products to market safely and efficiently. My ultimate goal is to be at the forefront of regulatory science, championing the development of safe, effective, and innovative healthcare solutions.

Experience

  1. Regulatory Specialist

    Berjé Inc

    Jan 2025 — Present · Carteret, NJ, US

Education

  • Sacred Heart High School & Junior College

    SSC, 10th Boards

  • Northeastern University

    Master of Science - MS, Regulatory Affairs

    2022 — 2024

  • Bharati Vidyapeeth

    Diploma in pharmacy

  • University of Mumbai

    Bachelor of Pharmacy - BPharm, Pharmacy

    2016 — 2019

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Aishwarya Shinde — Regulatory Specialist at Berjé Inc in Edison, NJ, US | Unifers