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Rajni Jha
Pharmaceutical Specialist
About
Bio
Rajni [An IIT Kanpur Scholar], an Independent Director with IOL Chemicals & Pharmaceuticals Limited, is a senior pharmaceutical regulatory, quality, and compliance professional with more than 33 years of pharmaceutical industry experience. Her career spans across departments such as:
- Chemical Research Division (R&D)
- Corporate Regulatory Affairs
- Development and Corporate Quality Assurance
- Drug Regulatory Affairs – RA & QA (R&D and manufacturing plant)
- Techno Commercial Team
She leads global inspections and audits, and supports techno-commercial and project management teams to align with business goals.
Career Highlights:
Rajni has held leadership roles in cross-functional teams at reputed pharmaceutical companies, including:
- Ranbaxy Research Laboratories
- Morepen
- Torrent Pharmaceuticals
- Glenmark Pharma
- Unimark Remedies
- Nicholas Piramal
- Indswift Laboratories
- Naari Pharma
- Freyr Global Regulatory Solutions
Her expertise includes API research, technology transfer and scale-up using Quality by Design (QbD), international regulatory affairs, corporate quality assurance, and navigating global audits and inspections.
She led teams through their first-ever USFDA audits, resulting in approvals from:
- USFDA
- EDQM
- MHRA
- KFDA
- NMO Greece
- TGA Australia
- PMDA (Japan)
She has also audited numerous domestic and international vendor sites for GMP/GxP compliance.
Current Role:
Rajni is now a freelance pharmaceutical consultant/advisor, offering:
- Expert guidance on regulatory and quality matters
- On-site and public training (technical and soft skills)
- GMP audits for drug substances and formulations
- Content development for pharma groups and academic institutions
She is a renowned speaker, faculty member, panelist, moderator, and host at global pharmaceutical regulatory and GMP conferences. Rajni is also an advisor on several boards of studies for pharmaceutical universities and magazines.
She has conducted numerous QbD workshops (both online and offline) and developed technical and soft skill modules, including those focused on women empowerment at the workplace.
Awards & Recognitions
- Feb 14, 2019 – 100 Most Impactful Healthcare Leaders (Global Listing) – World Health & Wellness Congress, Mumbai
- June 25, 2022 – Healthcare Innovation Award: Most Influential Pharmaceutical Personality of the Year
- Aug 26, 2022 – Exemplars of Excellence: Inspiring Health Entrepreneur of the Year – Mumbai
- Feb 15, 2023 – Most Motivational Pharmaceutical & Healthcare Mentor – Global Pharmaceutical-Healthcare-Technology Summit, New Delhi
- Nov 22, 2024 – Exemplars of Excellence Learning & Development (L&D) Award – Excellence in e-Learning – Pharma L&D & HR Summit (BlueTech Media), Mumbai
Key Expertise Zones
- Leadership by Example: Strategic execution and knowledge sharing across pharmaceutical domains.
- Commitment to Excellence: Integrity-driven communication, diligence, and continuous upskilling in academia and industry.
- Bridging Academia & Industry: Active participation as a steering/advisory board member to align education with industry needs.
- Revolutionizing Pharma Education: Creating customized hybrid modules and workshops to inspire and empower next-gen professionals.
- Pandemic Engagement: Spearheaded online educational and awareness campaigns during COVID-19, maintaining global engagement.
- Change Management: Ensures compliance with evolving regulatory and GMP guidelines through proactive regularization.
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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Total Articles
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