She is a senior RA professional, GMP consultant and Auditor and has over 27+ years of very versatile experience in pharmaceutical/Biotech 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 Managing Director of Raaj GPRACPVT. LTD. [‘Raaj Global Pharma Regulatory Affairs Consultants] Thane-Mumbai since 2010 and completed 10 successful years as women Entrepreneurship. Raaj GPRAC is an ISO29990-2010 certified institute.
She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.
Awarded for WIB-2019 by Indo Global Chambers of commerce on 7th April2019 at Indore.
--She brings with her more than 27+ years of rich experience working for leading organizations like SPECTRUM Pharmatech, SYNERGY PHARMA UAE, Raaj GPRAC, COGNIZANT , FAMYCARE , NOVARTIS, GSK-TCS, GLENMARK, SANDOZ, Ciba-Geigy, UNICHEM Labs, and LOCAL FDA, Bandra.
She is RAPS qualified and also hold 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 8500 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
A multi-faceted professional offering experience in HR Business Partnering; proficient in defining HR strategy consistent with business strategy & challenges and delivering sustained organizational growth in dynamic, highly competitive environment.
Achievement-oriented professional with 15 years of experience in Strategic HR Management in matrix structure with focus talent management, optimal utilization of resources, organization development, employee retention and change management.
Track record of delivering across global organizations like DHL, Deloitte Consulting and TATA AIG Life Insurance Services
Strategy architect credited with implementation of innovative and cost-effective HR initiatives to streamline business processes and capitalize on growth opportunities.
Experienced in Learning and Development, talent management, and succession planning f or improving the competence of the workforce and building talent pipeline.
Skilled in designing & applying a comprehensive performance management and competency framework to support business& achieve ambitious growth plans; managed the PMS for a headcount up-to 10000 plus
Leveraging analytical skills across competency & skill mapping, employee skill index, career paths, scenario analysis and performance reviews. Proficient in identifying training needs across levels, customizing the learning projects, conducting/imparting the trainings and measuring the effectiveness of these programs
Enterprising leader with excellent communication and people management skills for leading personnel towards accomplishment of common goals.
Feb 2013 to July 2015- Deloitte Consulting- US India offices as Performance Management Specialist
Delivered performance management cycle and succession planning for one of the largest consulting units having 10000+ employees for national and international locations
Defined the KPIs, Goals for the appraisal process and facilitated performance reviews, PIP planning and Intern Performance Management. Facilitated succession & career planning sessions for the leadership teams and provided analytics & HR support
Jul’08-Feb’13 with Deloitte Consulting- US, Hyderabad & Mumbai as Talent Development Manager
Led Learning & Development implementation agenda for 3 service lines in coordination with Global Learning Team with a team of 4 Executives. Assessed trainings needs, gaps, and development opportunities and designed high quality learning solutions with best-of-breed agencies. Successfully delivered programs on Leadership development and soft skills. Promoted as a Learning Lead for India office- Enterprise Risk Services in December 2010 .Recognized as the Employee of the Month & Quarter and with SPOT Awards several times.
Richard Bandler Certified Neuro Linguistic Programming Practitioner May 2009
Certified and Licensed to administer the Thomas Personal Profile Analysis and its related instruments for Job Analysis, TNA and Training Effectiveness Monitoring
Certified Trainer with Credits for the City and Guilds International Training and Teaching program (1104)-UK in 2004
Dell- USA Certified Communication and Voice and Accent Trainer in 2005
Pragati Leadership Institutes “Inspiring Facilitator”-Train the Trainer Program in 2004
FORTY years of wide and varied experience in API business involving:
The Key Deliverables:
A regulatory affairs professional backed up with experience in Pharmaceuticals, Medical devices, and Consumer healthcare products (OTCs). A dedicated, highly regarded professional with a wealth of transferable skills and a strong academic background. He possess12 years experience of pharmaceutical manufacturing & 25 years experience as a Drug regulator. Possesses excellent interpersonal and communication skills and the ability to get along with all levels of personnel. A resourceful, dedicated, hard-working, driven and highly committed individual with natural leadership skills.
Adviser to Pharmaceutical and Allied Industry (Food /Devices /Cosmetics etc ) on Techno legal issues pertaining to special acts like Drugs & Cosmetics Act & Drugs Price control, FSSAI . Have been associated with DCGI , FDA, CDTL, CDL, FSSAI New Delhi and FSSAI zonal offices. Well versed in the area of licence, registration , renewal, and maintenance for drugs and registration and maintenance and labeling of food under the new regulations of FSSAI
January 2008-May 2014 Mumbai area, India
To provide recommendations for registration/licensing of Pharmaceutical manufacturing units under the provision of the Drug & Cosmetic Act of India.
Approval of Drug formulations [biological and non-biological] before manufacturing.
Recommendation for registration of manufacturing units that fulfill all the criteria under WHO Good Manufacturing Practices [GMP] in coordination with Central drug authority.
Technical Consultations for the layout plan of pharmaceutical manufacturing units to ascertain that manufacturing activities are carried out as per GMP standards.
Quality Assurance: To ascertain that the manufacturing units are implementing all the Quality control parameters required for the drug manufacturing as per WHO GMP and amended schedule “M” and schedule “T” of Drug & Cosmetic Act of India.
Blood Bank: Recommendation for the licensing/registration of blood bank units for proper layout planning and equipment’s required for testing.
To establish coordination with office of National Pharmaceutical Pricing Authority of India to establish that the prices of formulation drugs are manufactured within the ceiling price as fixed by Govt. of India.
To recommend the quota for a particular Narcotic drug under the provision of Narcotic Drug & Psychotropic substance Act of India.
Drugs Inspector 1990 -2008
Statutory audit of Retail and Wholesale drug establishments, manufacturing units and blood banks.
To inspect the manufacturing units for Registration and Licensing as per the provisions laid down under amended schedule “M” and schedule “T” of Drugs & Cosmetic Act.
Inspection of blood banks for licensing the whole blood/blood components as per schedule “F (part XIIB)” of Drugs & Cosmetic Act.
Unearthed the interstate rackets of spurious drugs and launched prosecutions in the court of law for spurious & drugs declared not of standard quality as well as the establishments running without valid drug manufacture /sale license.
Well versed with the manufacturing oral doses form, general SOP , documentation, general compliance ,training and setting of new plant
Highlights of experience and achievements
I. He was elected to the prestigious post of Vice-President, & Chairman of Regulatory Affair Div Indian Pharmaceutical Association in December 2010-12.
II. He has an extensive experience in regulatory field and held important positions in FDA Maharashtra such as Assistant Commissioner (Intelligence Branch) His contribution and professional excellence has been recognized by way of awards and recognition:
III. He is a good orator, communicator and a trainer, a fact recognized by national and international organizations by inviting him as faculty for seminars and workshops. He loves teaching and regularly shares his thoughts with the students of pharmacy, the Drugs Control Officers, the Professionals in Industry, Community Pharmacy and Consumer Organization.
IV. He is founder member of of the All India Drugs Control Officers' Confederation and has served AIDCOC. He has played a very vital role in Indian Pharmaceutical Association Maharashtra State Branch and was Secretary & as the President from 2004 to 2006 and during his tenure of President he has achieved “Best State Branch award “ twice.