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Rajni Jha
Pharmaceutical Specialist
About
Bio
Rajni Jha [An IIT Kanpur Scholar], Ex Vice President Regulatory Affairs ,is a Senior Pharmaceutical Regulatory, Quality & Compliance professional with ~ 32 years of Pharmaceutical industry experience across different Departments - Chemical Research Division
[RnD], Corporate Regulatory Affairs, Development and Corporate Quality Assurance, Drug Regulatory Affairs- RA & QA[RnD & Manufacturing plant] &Techno Commercial Team.
She has successfully led her teams during Regulatory Audits & Inspections for the first-ever USFDA audit of a few organizations she worked with leading to many facility approvals wrt USFDA, EDQM, MHRA, KFDA, NMO Greece, TGA Australia and PMDA for both APIs & Formulations[via multiple Marketing procedures in global markets]. She has audited numerous domestic as well as International outsourced vendor sites (of Regulatory Starting Materials & APIs)for GMP/GXP Compliance.
Key Expertise Zones -
1. Continuous dissemination of knowledge via rich Experience & Expertise across Industry by Leading as example as an Pharmaceutical Leader - Industry professional & Consultant – Translating Strategy into action on the shop floor
2. Extending boundaries of excellence by due diligence ,communication, integrity & all round up-skilling & Up-gradation across Academicia & Industry
3. Constant efforts for Bridging Gap between Pharma Academics curriculum & Industry Expectations as an Industry Resource person on board as a steering committee/Advisory Board on several Institutions – Government as well as Private since many years
4. Revolutionization of Pharma Education Pedagogy via Customized Modules/Workshops & Lectures through Hybrid mode- On site as well as online e-learning videos, eLMS Upgradation across various Industries- Reaching out, motivating & Inspiring Gen Next!
5. Maneuvering through Covid-19 debacle for more than two years by online mode with Academic Institutions, Industry & Society for awareness, precautions & Vaccine campaign – ensured engagement, connection & collaboration with Professionals & Public globally.
6. Change Management Regularization vis-à-vis current Regulatory & GMP Guidelines.
Professional
General Manager , Freyr Solutions
(July 2023 - March 2024)
Head Of Regulatory Affairs , Naari Pharma
(April 2017 - September 2023)
Senior General Manager Corporate RA / QA , Ind Swift
(May 2010 - December 2012)
General Manager Regulatory Affairs , Glenmark Generics Ltd.
(November 2006 - May 2010)
Senior General Manager RA and QA , Unimark Remedies Limited
(August 2005 - July 2006)
Manager CQA/RA , Torrent Pharmaceuticals Ltd
(April 2003 - January 2005)
Assistant General Manager , Nicholas Piramal India Ltd
(June 1905 - June 1905)
Senior Research Scientist , Ranbaxy Laboratories Pvt Ltd
(June 1905 - June 1905)
Awards and Accolades
100 Most Impactful Healthcare Leaders , World Health & Wellness Congress , January 2019
Most Influential Pharmaceutical Personality of the Year , Healthcare Innovation Award , January 2022
Exemplars of Excellence Award , Inspiring Health Entrepreneur , January 2022
Most Motivational Pharmaceutical & Healthcare Mentor , Global Pharmaceutical Healthcare Technology Summit , January 2023
Active Contributor
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