Manan Gabani Email & Phone Number

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.