
Neeraj Mehta
With over two decades of experience in the realm of pharmaceutical regulatory affairs, I have built a solid... | India
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Neeraj Mehta’s Emails ne****@no****.com
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Neeraj Mehta’s Location India
Neeraj Mehta’s Expertise With over two decades of experience in the realm of pharmaceutical regulatory affairs, I have built a solid foundation working with leading organizations such as Novartis Health Care Ltd, Ranbaxy Laboratories Ltd, and Jubilant Generics Ltd. My domain expertise lies primarily in regulatory affairs related to drug substances. As a leader, I've been instrumental in formulating and implementing global CMC regulatory strategies, not only for development projects but also for marketed products. A key part of my role involves authoring comprehensive, high-quality CMC documentation and actively contributing to, reviewing, and supervising the development of CMC templates and procedures. Exemplifying qualities like accountability, long-term vision, confidence, people-orientation, and emotional stability, I've successfully managed and led cross-functional, geographically dispersed teams. I've been persistent in maintaining and enhancing the quality of work output, supporting quality improvement initiatives wherever appropriate. Regularly conducting regulatory compliance audits and providing timely, high-quality advice on regulatory evaluations (such as change controls for marketed drug substances) are an integral part of my role. I am known for my ability to swiftly identify the necessary documentation and any associated issues for global submissions, and for negotiating the delivery of approved technical source documents in line with project timelines. Additionally, I've managed approximately 13 contract manufacturing locations for regulatory submissions and have overseen regulatory audits as the site regulatory in-charge for a plethora of agencies including the US FDA, TGA, Japan, Korea, and Europe. My specialties lie in Pharmaceutical Regulatory Affairs (API), and compliance activities concerning Regulatory Affairs. I've had direct interaction with USFDA, EDQM, and EU GMP Auditors as a key regulatory affairs personnel.
Neeraj Mehta’s Current Industry Jubilant Pharmova
Neeraj
Mehta’s Prior Industry
Ranbaxy
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Novartis
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Jubilant Generics
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Jubilant Pharmova
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Work Experience

Jubilant Pharmova
Head Api Regulartory Affairs (Director- Regulatory Affairs)
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Jubilant Generics
Head Api Regulatory Affais (Dgm)
Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Reg Cmc Manager
Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Ranbaxy
Senior Research Scientist (A3)
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue May 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Ranbaxy
Senior Resarch Scientist (A2)
Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Ranbaxy
Resarch Scientist
Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Ranbaxy
Officer Regulatory Affairs
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Ranbaxy
Supervisor Regulatory Affairs (S03)
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)