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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.
Knovea Pharmaceutical Pvt. Ltd.
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Deputy General ManagerKnovea Pharmaceutical Pvt. Ltd. Jan 2024 - Present
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Senior ManagerNivagen Pharmaceuticals, Inc. Apr 2020 - Mar 2024Ahmedabad, Gujarat, India- 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 manufacturing organizations (CMOs) across multiple countries, including Germany, Argentina, Taiwan, USA, and Bangladesh, as a part of Nivagen's Global Partnership model -
ManagerNivagen Pharmaceuticals, Inc. Aug 2018 - Apr 2020- 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 -
ExecutiveAmneal Pharmaceuticals Apr 2016 - Aug 2018Ahmedabad, Gujarat, IndiaContributed for submission of US - ANDAs and Deficiency responses (IR / CR / DRL / Patent Amendments / Administrative Amendments) for Oral Solid Dosage Forms -
Sr. OfficerApothecon Pharmaceuticals Pvt. Ltd. Jun 2013 - Apr 2016Vadodara, Gujarat, IndiaResponsible 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 -
Research ScientistFresenius Kabi Oncology Limited. - India Sep 2012 - Jun 2013Gurugram, Haryana, IndiaContributed to the compilation and submission of the dossier for the GCC Market, specifically Saudi Arabia, Lebanon and Oman -
Regulatory AssistantSun Pharmaceutical Industries Ltd Aug 2008 - Oct 2010Vadodara, Gujarat, India- 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
Nirav Sheth Education Details
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Quality Assurance -
Bachelor Of Pharmacy - Bpharm
Frequently Asked Questions about Nirav Sheth
What company does Nirav Sheth work for?
Nirav Sheth works for Knovea Pharmaceutical Pvt. Ltd.
What is Nirav Sheth's role at the current company?
Nirav Sheth's current role is DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market.
What is Nirav Sheth's email address?
Nirav Sheth's email address is ns****@****gen.com
What schools did Nirav Sheth attend?
Nirav Sheth attended K.b.institute Of Pharmaceutical Education & Research, Rajiv Gandhi University Of Health Sciences.
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Nirav Sheth
Serial Entrepreneur L Investor Relations L Structured Debt L Offshore Debt L Startup Growth Partner L Public Policy Enthusiast L InvestorAhmedabad -
3edelweissfin.com, sbicapsec.com, emkayglobal.com
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Nirav Sheth
Mumbai2gmail.com, timesgroup.com
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