Directory

>

John Pakulski

avatar

John Pakulski

SVP Global Regulatory Affairs | Kashiv BioSciences LLC

United States

View contact details (it's free)

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.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

John Pakulski

Work Experience

company logo

SVP Global Regulatory Affairs at

Prolong Pharmaceuticals

March 2021 - Present

company logo

SVP Regulatory Affairs & Clinical Development at

Kashiv BioSciences LLC

April 2020 - Present

company logo

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

company logo

Head Global Regulatory Science, Biologics at

Viatris, Inc.

November 2015 - December 2017

company logo

Head US Biopharmaceutical Regulatory Affairs at

Sandoz

November 2009 - October 2015

Logos provided by Logo.dev

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

mail

*********@kashivpharma.com

*********@prolongpharma.com

Colleagues

avatar
Naitik Shah

Associate Vice President Finance

Sandeep Gupta

Chief Executive Officer

avatar
Kandarp Raval

Associate Vice President

avatar
Kaushal Joshi

Associate Vice President

avatar
Paras Vasanani

Vice President & Global head-BD&L/MA, Porfolio, Strategy & Project Management

avatar
Chandramauli Rawal

Chief Operating Officer

avatar
James Fitzpatrick

Vice President Human Resources

avatar
Jignesh Dave

Associate Vice President IT

avatar
Wantanee Phuapradit

Executive Vice President

View Contact details (it's free)
Request Profile Removal