Rajni Jha

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.

M.Sc. Chemistry

Chhatrapati Shahu Ji Maharaj University (1982 - 1986)

Pharmaceutical Specialist

Freelance (Mar 2024 - Present)

General Manager

Freyr Solutions (Jul 2023 - Mar 2024)

Head Of Regulatory Affairs

Naari Pharma (Apr 2017 - Sep 2023)

Senior General Manager Corporate RA / QA

Ind Swift (May 2010 - Dec 2012)

General Manager Regulatory Affairs

Glenmark Generics Ltd. (Nov 2006 - May 2010)

Senior General Manager RA and QA

Unimark Remedies Limited (Aug 2005 - Jul 2006)

Manager CQA/RA

Torrent Pharmaceuticals Ltd (Apr 2003 - Jan 2005)

Assistant General Manager

Nicholas Piramal India Ltd (2005)

Senior Research Scientist

Ranbaxy Laboratories Pvt Ltd (1992 - 2002)

100 Most Impactful Healthcare Leaders, World Health & Wellness Congress, February 2019

Healthcare Innovation Award for Most Influential Pharmaceutical Personality of the Year, June 2022

Exemplars of Excellence Award under Inspiring Health Entrepreneur, August 2022

Most Motivational Pharmaceutical & Healthcare Mentor, Global Pharmaceutical Healthcare Technology Summit, February 2023