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John Pakulski
John Pakulski
SVP Global Regulatory Affairs | Kashiv BioSciences LLC
United States
John Pakulski
Summary
John Pakulski is a seasoned executive with over 35 years of experience in regulatory affairs, specializing in the development and approval of biosimilars and biologics. As the SVP of Regulatory Affairs & Clinical Development at Kashiv BioSciences, he has played a pivotal role in shaping regulatory pathways in the U.S. for biosimilars. John has led regulatory teams for two decades, demonstrating exceptional leadership in global regulatory affairs. He has successfully overseen the approval of multiple biosimilars and has contributed to significant regulatory submissions during his tenure at major pharmaceutical companies such as Mylan and Sandoz. His extensive background includes a focus on clinical development, drug regulations, and strategic regulatory submissions across various therapeutic areas. A graduate of Rutgers College of Pharmacy, John combines his pharmaceutical expertise with a strategic vision for regulatory compliance and innovation in drug development. His leadership has not only advanced the companies he has worked for but has also influenced the broader pharmaceutical landscape.
John Pakulski
Work Experience
SVP Global Regulatory Affairs at
Prolong Pharmaceuticals
March 2021 - Present
SVP Regulatory Affairs & Clinical Development at
Kashiv BioSciences LLC
April 2020 - Present
Senior VP Global Regulatory Affairs at
Kashiv BioSciences LLC
January 2019 - April 2020
Regulatory Affairs and Drug Development Consultant at
John Pakulski Consulting
September 2018 - December 2018
Head Global Regulatory Science, Biologics at
Viatris, Inc.
November 2015 - December 2017
Head US Biopharmaceutical Regulatory Affairs at
Sandoz
November 2009 - October 2015
John Pakulski
Education
Rutgers University, College of Pharmacy
Frequently Asked Questions about John Pakulski
What is John Pakulski email address?
John Pakulski's primary email address is *********@kashivpharma.com. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does John Pakulski work for?
John Pakulski is a SVP Global Regulatory Affairs at Kashiv BioSciences LLC, a company specializing in Pharmaceutical & Medicine Manufacturing.
Where John Pakulski graduated from?
John Pakulski holds a degree in from Rutgers University, College of Pharmacy.
How can I directly contact John Pakulski?
To contact John Pakulski directly, you can use the email address *********@kashivpharma.com. Complete contact information is available upon registration with Muraena.
Who is John Pakulski?
John Pakulski is a seasoned executive with over 35 years of experience in regulatory affairs, specializing in the development and approval of biosimilars and biologics. As the SVP of Regulatory Affairs & Clinical Development at Kashiv BioSciences, he has played a pivotal role in shaping regulatory pathways in the U.S. for biosimilars. John has led regulatory teams for two decades, demonstrating exceptional leadership in global regulatory affairs. He has successfully overseen the approval of multiple biosimilars and has contributed to significant regulatory submissions during his tenure at major pharmaceutical companies such as Mylan and Sandoz. His extensive background includes a focus on clinical development, drug regulations, and strategic regulatory submissions across various therapeutic areas. A graduate of Rutgers College of Pharmacy, John combines his pharmaceutical expertise with a strategic vision for regulatory compliance and innovation in drug development. His leadership has not only advanced the companies he has worked for but has also influenced the broader pharmaceutical landscape.
John`s contact details
*********@kashivpharma.com
*********@prolongpharma.com
Colleagues
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