Rajashri Ojha's Biography

Rajashri Ojha, Founder & Director, Raaj Global Pharma Regulatory Affairs Consultants

Mrs. Rajashri Ojha is a Pharmacist and has over 21+ years of very versatile experience in pharmaceutical industry, starting her career FROM Scientist in R & D, Analytical, Formulation Development, Technical/CMC Documentation, QC-QA-QM, Till the Registration & marketing approvals of drug products across the globe. She also hold Diploma in Intellectual Property rights (IPR), Pharma Quality Management and is a Regulatory Submission expert of CTD/eCTD/ACTD/NeeS formats.
She brings with her more than 2 decades of rich experience working for leading organizations like Cognizant, Raaj GPRAC, Novartis, Glenmark, Sandoz-Ciba Geigy, GSK-TCS, Famycare, Unichem Laboratories and local FDA, Bandra.
Competent, diligent & result oriented professional experienced in Strategic Management, New Organizational Set-ups, Project Management, Resource Management, Compliance Management , Regulatory Submission Management across the globe.
She was a Founder and former Director of Raaj Global Pharma Regulatory Affairs Consultants, Thane-Mumbai (Raaj GPRAC). She has published more than 15 Articles and Research papers in reputed journals.
Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products. Handled submissions of IND/NDA/ANDA/ANDs to different National & International Health Authorities. Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, WHO and other local Health Authorities.
She is also associated with many leading education institutes/colleges in India as a ‘Guest faculty’. Trained more than 3000 candidates till now on various aspects of Regulatory Affairs, Global Submissions, Quality Assurance, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc in Pharma industry.
She is a Visiting faculty (Adjunct Professor)at JSS University in Mysore for ‘M.Pharm in Drug Regulatory Affairs’. Also she is a member of IPA, DIA, IDMA, RAPS, TOPRA, OMICS, FIP, UBM, Global Compliance Panel etc. and Chaired many scientific sessions organized for National and International Conferences.
Rajashri currently working in COGNIZANT Life Science-BPS as a Project Manager for ‘Regulatory Intelligence’ and supporting Cognizant in setting up of new business process and operations of ‘Regulatory Affairs’ and ‘Regulatory Intelligence’.