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
Regulatory Specialist
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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