Currently, I am expanding my expertise at Northeastern University, pursuing a Master’s in Regulatory Affairs with an expected graduation in June 2025. In my recent role as a Regulatory Affairs Associate at Glasston Pharmaceuticals, I actively managed regulatory submissions, ensured FDA compliance, and conducted rigorous quality control tests. My role involved drafting and reviewing, maintaining, and keeping records of regulatory strategies and annual reports, aligning them with the stringent FDA guidelines to support our product development goals. This position allowed me to sharpen my skills in regulatory writing, project management, and cross-functional collaboration, directly contributing to the successful approval of multiple submissions.With a solid educational background in pharmacy from INDUKAKA IPCOWALA COLLEGE OF PHARMACY, New V.V. Nagar, and hands-on experience in regulatory affairs, I have developed critical competencies in Chemistry, Manufacturing, and Controls (CMC), and labeling. My certifications in Drug Regulatory Affairs, Regulatory Affairs & Medical Writing, and Medical Device Regulation 2017/745 EU further demonstrate my commitment to maintaining the highest standards of public health and pharmaceutical product safety.In addition to these technical skills, I bring a thorough understanding of FDA regulations, expertise in compiling Investigational New Drug (IND) applications, and a proactive approach to ensuring compliance with current Good Manufacturing Practices (cGMP). By combining academic knowledge with practical experience, I aim to contribute to the ongoing development of high-quality, safe pharmaceutical products that adhere to global regulatory requirements.
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Quality Assurance AssociatePls AnalyticalBoston, Ma, Us -
Residential Security OfficerResidential Security Office At Northeastern University Dec 2024 - PresentBoston, Massachusetts, United States -
Regulatory Affairs Associate, Regulatory Submissions And Document ManagementGlasston Pharmaceuticals Jun 2022 - Nov 2022India• Managed regulatory submissions and project management activities to ensure compliance with FDA regulations and international standards.• Conducted rigorous quality control tests on pharmaceutical products to verify potency and purity.• Contributed to the development of annual reports and regulatory strategies aligned with FDA expectations.
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PharmacistApple Pharmacy Jun 2021 - Aug 2021IndiaDeveloped a strong foundation in regulatory compliance and legal knowledge within the pharmacy setting.• Ensured adherence to pharmaceutical laws and regulations for safe and effective medication dispensing.• Maintained accurate records and documentation to support audit readiness and smooth pharmacy operations.
Manan Gabani Education Details
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Pharmacy Administration And Pharmacy Policy And Regulatory Affairs
Frequently Asked Questions about Manan Gabani
What company does Manan Gabani work for?
Manan Gabani works for Pls Analytical
What is Manan Gabani's role at the current company?
Manan Gabani's current role is Quality Assurance Associate.
What schools did Manan Gabani attend?
Manan Gabani attended Northeastern University, Indukaka Ipcowala College Of Pharmacy, New V.v.nagar 223.
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Manan Gabani
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Manan Gabani
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