Nirav Sheth

Nirav Sheth Email and 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 @
Nirav Sheth's Location
Ahmedabad, Gujarat, India, India
Nirav Sheth's Contact Details

Nirav Sheth work email

Nirav Sheth personal email

n/a
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.

Nirav Sheth's Current Company Details
Knovea Pharmaceutical Pvt. Ltd.

Knovea Pharmaceutical Pvt. Ltd.

DGM | Regulatory Affairs | CMC Strategist | Sterile Injectables | Oral Solid Dosage Form | Helping Pharma Companies to Set up & Drive Regulatory Operations for US Market
Nirav Sheth Work Experience Details
  • Knovea Pharmaceutical Pvt. Ltd.
    Deputy General Manager
    Knovea Pharmaceutical Pvt. Ltd. Jan 2024 - Present
  • Nivagen Pharmaceuticals, Inc.
    Senior Manager
    Nivagen Pharmaceuticals, Inc. Apr 2020 - Mar 2024
    Ahmedabad, 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
  • Nivagen Pharmaceuticals, Inc.
    Manager
    Nivagen 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
  • Amneal Pharmaceuticals
    Executive
    Amneal Pharmaceuticals Apr 2016 - Aug 2018
    Ahmedabad, Gujarat, India
    Contributed for submission of US - ANDAs and Deficiency responses (IR / CR / DRL / Patent Amendments / Administrative Amendments) for Oral Solid Dosage Forms
  • Apothecon Pharmaceuticals Pvt. Ltd.
    Sr. Officer
    Apothecon Pharmaceuticals Pvt. Ltd. Jun 2013 - Apr 2016
    Vadodara, Gujarat, India
    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
  • Fresenius Kabi Oncology Limited. - India
    Research Scientist
    Fresenius Kabi Oncology Limited. - India Sep 2012 - Jun 2013
    Gurugram, Haryana, India
    Contributed to the compilation and submission of the dossier for the GCC Market, specifically Saudi Arabia, Lebanon and Oman
  • Sun Pharmaceutical Industries Ltd
    Regulatory Assistant
    Sun Pharmaceutical Industries Ltd Aug 2008 - Oct 2010
    Vadodara, 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

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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