Mrs.Rajashri Survase-Ojha is a senior RA professional, GMP consultant and Lead Auditor-13485-2016 and has over 27+years of very versatile experience in pharmaceutical industry, starting her career FROM Scientist in R&D,[Analytical & Formulation],QA-QM, till GLOBAL regulatory Affairs. Expertise in getting marketing approvals of Generics, DRUG SUBSTANCE/DRUG PRODUCTS/MEDICAL DEVICES/OTC/Neutraceuticals & FOOD across the Globe.
Rajashri is the founder and Director in RAAJ GPRAC & RAAJ PHARMA eLearning, Thane-Mumbai since 2009- 2010 and completed 10 successful years as women Entrepreneurship. Raaj GPRAC is NSDC-LSSSDC Accreditated and an ISO 29993-2017certifiedinstitute.
She is RAPS qualified and also holds PG Diploma in Intellectual Property rights (IPR), Pharma Quality Management and is a Regulatory Submission expert of CTD/eCTD/ACTD/NeeS formats. She has TRAIN the TRAINER, Six Sigma Green belt, 7 habits of most effective people and Cornerstone leadership certifications.
She has published more than 18 Articles and Research papers in reputed journals.
She has Trained more than 15000 candidates till now on various aspects of GLOBAL Regulatory Affairs, GMP, GLP, GCP, GDP, Country-specific Regulatory Submissions(USFDA, EMA, ROW, ANVISA, WHO, ASEAN, SFDA, CDSCO-DCGI & Others), Quality Assurance & COMPLIANCE, 21CFR PARTS, GAMP-5, CSV, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc in Pharma & Biotech industry.
Hands on expertise in Regulatory Affairs(RA) and ‘Regulatory Intelligence’(RI) and setting up of new business process and operations of ‘Regulatory Affairs’ and ‘Regulatory Information Management (RIM)’ and Training centers across the globe.
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.
Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products. -Handled submissions of DMF, KDMF, ASMF, CEP/CoS and IND/NDA/ANDA/ANDs to different National & International Health Authorities. Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, ANVISA, TGA, SFDA, TFDA, MHLW/PMDA, WHO and other local Health Authorities.
She is also associated with many leading education institutes/colleges in India as a ‘Guest faculty’
She is a Visiting faculty (Adjunct Professor)at JSS University in Mysore for ‘M.Pharm in Drug Regulatory Affairs’. ICT-UDCT, BCP, KLE, MET, NIPER, Sinhagad institutes, Bharati Vidyapith, Gehlot, HKCP, OCP etc.
She is a member of IPA, DIA, IDMA, RAPS, TOPRA, OMICS, FIP, UBM, Global Compliance Panel, IMS, IBC etc. and Chaired many scientific sessions organized for National and International Conferences. ASQ Member ID: 65583963
- Received a Sandoz award for Excellence in December 2004 for the Best Individual Contribution
- Received a Best team support award for ANDA filings in Sandoz.
- Received many Token of Appreciation from various Pharma colleges and Institutes from all over India.
- She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.
- LEAD AUDITOR-13485[QMS- Medical Devises]
- Six Sigma Green Belt trained
- ‘Train the Trainer’ Certifications
- Hands on eCTD certification
- PG Diploma in Patents, Quality Assurance and QM
- Certification in Cornerstone Leadership program designed for Sr. Managers in Hyderabad
- ISO 29990-2010
- LSSSDC Accreditation