Deputy General Manager
Current
Knovea Pharmaceutical Pvt. Ltd.
Jan 2024 - Present
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Nirav Sheth Email & Phone Number
DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market
at
Knovea Pharmaceutical Pvt. Ltd.
1 work email found
@nivagen.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 86%
Current company
Knovea Pharmaceutical Pvt. Ltd.
Role
DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market
Location
Ahmedabad, Gujarat, India
Who is Nirav Sheth? Overview
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Quick answer
Nirav Sheth is listed as DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market at Knovea Pharmaceutical Pvt. Ltd., based in Ahmedabad, Gujarat, India. AeroLeads shows a work email signal at nivagen.com and a matched LinkedIn profile for Nirav Sheth.
Nirav Sheth previously worked as Deputy General Manager at Knovea Pharmaceutical Pvt. Ltd. and Senior Manager at Nivagen Pharmaceuticals, Inc.. Nirav Sheth holds Master Of Pharmacy, Quality Assurance from K.B.Institute Of Pharmaceutical Education & Research.
Company email context
Email format at Knovea Pharmaceutical Pvt. Ltd.
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{first_initial}{last}@nivagen.com
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AeroLeads found 1 current-domain work email signal for Nirav Sheth. Compare company email patterns before reaching out.
Profile bio
About Nirav Sheth
Initiating my career as a generic drug programmer for the ROW (Latam & GCC) and Europe Market, I have predominantly worked for the US market for both solid oral and injectable formulations. At present, I spearhead the Regulatory Team, responsible for US Regulatory Market Operation encompassing Development, IND, NDA, ANDA Submissions, Deficiency Responses Review, Approvals, and Post-Approval Activities for the entire Injectable Portfolio using the ACE Model (Application Quality, Communication Effectiveness between FDA-Applicant, Efficient Review). I endeavor pharma companies with US regulatory market operations and generic drug life cycle management for injectable formulations to obtain first-cycle approval. I’m grateful to my professional mentors, peers, and team members for inspiring me to evolve into a better RA professional.
Current workplace
Nirav Sheth's current company
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Knovea Pharmaceutical Pvt. Ltd.
7 roles
Nirav Sheth work experience
A career timeline built from the work history available for this profile.
Senior Manager
- Promoted for outstanding performance (Achieved 7+ ANDA Approval)- Primary accountable person for CMC programs managing daily delivery of regulatory and strategic activities including ANDAs/INDs/amendments submission, post-approval changes (PAS/CBE/AR), and ongoing compliance of commercial products for US market - Collaborated closely with contract.
Apr 2020 - Mar 2024
Manager
- Spearhead the Regulatory Team; planning, organizing and supervising the working of regulatory team - Initiated and oversaw the setting up of Nivagen (India) - Start Up for US Regulatory Market Operation, developing and implementing regulatory strategies for generic filings - 505(j), specifically targeting sterile formulations
Aug 2018 - Apr 2020
Executive
Contributed for submission of US - ANDAs and Deficiency responses (IR / CR / DRL / Patent Amendments / Administrative Amendments) for Oral Solid Dosage Forms
Apr 2016 - Aug 2018
Sr. Officer
Responsible for DMFs, ANDAs and Post-approval supplements (AR/CBE/PAS) submission for US Market and DCPs submission for Europe Market for oral solid dosage forms and sterile injectables
Jun 2013 - Apr 2016
Research Scientist
Contributed to the compilation and submission of the dossier for the GCC Market, specifically Saudi Arabia, Lebanon and Oman
Sep 2012 - Jun 2013
Regulatory Assistant
- Contributed to the compilation and submission of the dossier for the Latam Region, including Venezuela, Colombia, Peru, Panama, and Brazil- Created digital database for COPPs, Manufacturing Licenses and Product Permissions of 1200+ products on IDMLA Portal of FDCA - Gujarat state
Aug 2008 - Oct 2010
2 education records
Nirav Sheth education
Master Of Pharmacy, Quality Assurance
Bachelor Of Pharmacy - Bpharm
FAQ
Frequently asked questions about Nirav Sheth
Quick answers generated from the profile data available on this page.
What company does Nirav Sheth work for?
Nirav Sheth works for Knovea Pharmaceutical Pvt. Ltd..
What is Nirav Sheth's role at Knovea Pharmaceutical Pvt. Ltd.?
Nirav Sheth is listed as DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market at Knovea Pharmaceutical Pvt. Ltd..
What is Nirav Sheth's email address?
AeroLeads has found 1 work email signal at @nivagen.com for Nirav Sheth at Knovea Pharmaceutical Pvt. Ltd..
Where is Nirav Sheth based?
Nirav Sheth is based in Ahmedabad, Gujarat, India while working with Knovea Pharmaceutical Pvt. Ltd..
What companies has Nirav Sheth worked for?
Nirav Sheth has worked for Knovea Pharmaceutical Pvt. Ltd., Nivagen Pharmaceuticals, Inc., Amneal Pharmaceuticals, Apothecon Pharmaceuticals Pvt. Ltd., and Fresenius Kabi Oncology Limited. - India.
How can I contact Nirav Sheth?
You can use AeroLeads to view verified contact signals for Nirav Sheth at Knovea Pharmaceutical Pvt. Ltd., including work email, phone, and LinkedIn data when available.
What schools did Nirav Sheth attend?
Nirav Sheth holds Master Of Pharmacy, Quality Assurance from K.B.Institute Of Pharmaceutical Education & Research.
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