Rajni Madhu is a seasoned professional in regulatory affairs with extensive experience across various companies in the biopharmaceutical industry. Currently serving as Senior Manager of Regulatory Affairs at Ocular Therapeutix, Inc. since October 2021, Rajni has successfully led regulatory projects to align with strategic development plans and managed numerous regulatory submissions, including IND and NDA applications. Previous roles include Regulatory Affairs Manager at Fulcrum Therapeutics and Regulatory Affairs Specialist III at BioPoint, where responsibilities encompassed managing regulatory submissions and supporting clinical studies. Starting as a Regulatory Affairs Associate at TARIS Biomedical, Rajni contributed to compliance with regulatory requirements for active clinical studies. Educational qualifications include a Master’s Degree in Project Management focused on Regulatory Affairs from Northeastern University, an MBA in Human Resources Management from Indira Gandhi National Open University, and a Bachelor’s Degree in Homeopathic Medicine from Hemchandracharya North Gujarat University.
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