Prajakta K.
About Prajakta K.
Prajakta K. is a Senior Manager at Bristol Myers Squibb, specializing in EU CTA Submission Management with extensive experience in regulatory affairs and clinical trial applications.
Current Role at Bristol Myers Squibb
Prajakta K. currently holds the position of Senior Manager EU CTA Submission Management at Bristol Myers Squibb. Located on-site, she leads efforts related to managing clinical trial applications within the European Union. Her responsibilities include overseeing the entire submission process and ensuring regulatory compliance.
Previous Experience at Merck Group
From 2022 to 2023, Prajakta K. worked as a Regulatory Affairs Manager at Merck Group in Bengaluru, Karnataka, India. In this role, she focused on regulatory submissions, aiming to achieve and maintain compliance with local and international regulatory standards. She managed complex regulatory affairs tasks effectively during her tenure.
GSK Position and Responsibilities
Prajakta K. served as a Senior Regulatory Affairs Specialist - Submission Lead (Clinical Trial Application CTA) at GSK from 2021 to 2022 in Bengaluru, Karnataka, India. During this period, her main focus was on leading the CTA submission process for clinical trials. She ensured thorough planning and coordinated submissions to meet regulatory requirements within stipulated timelines.
Tenure at IQVIA
Prajakta K. held two positions at IQVIA, first as a Regulatory Affairs Specialist (2016-2018) and then as a Senior Regulatory Affairs Associate (2019-2021) in Maharashtra, India. She managed regulatory affairs and study start-up procedures, contributing significantly to the firm's regulatory compliance and successful project start-ups.
Educational Background
Prajakta K. earned a Master of Science (MS) in Biology/Biological Sciences from Savitribai Phule Pune University. Additionally, she holds a Bachelor of Science (BS) in Biotechnology from Shivaji University. Her educational background has equipped her with a solid foundation in biological sciences and biotechnology.
Team Leadership and Training
In her career, Prajakta has demonstrated strong leadership skills by leading a team of seven in managing EU CTA transitions to EU CTR. She has conducted training sessions on the EU CTR submission transition process and ensured that her team was well-prepared to handle regulatory requirements.
Expertise in Therapeutic Areas
Prajakta K. possesses expertise in a variety of therapeutic areas, including Oncology, Immunology, Respiratory, Cardiovascular Disease, Infectious diseases, Neuroscience, and Rheumatic conditions/Rheumatology. Her broad knowledge base allows her to navigate complex therapeutic landscapes effectively.