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Paul Kirsch

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Paul Kirsch

Vice President, Regulatory Affairs | Harmony Biosciences

Malvern, Pennsylvania, United States

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Paul Kirsch

Summary

Paul Kirsch is a seasoned executive with extensive experience in Regulatory Affairs within the pharmaceutical industry. He currently serves as the Vice President of Regulatory Affairs at Harmony Biosciences, where he oversees regulatory strategies and submissions. With a career spanning over three decades, Paul has held leadership positions at various pharmaceutical companies, including Zynerba Pharmaceuticals and Trevena. His expertise encompasses both US and International Regulatory Affairs, with a strong focus on clinical development and drug registration. Paul is known for his strategic insight into health agency liaison activities and corporate due diligence. He holds a Bachelor of Science in Biology from the University of Scranton. His passion for the biopharmaceutical sector is evident in his commitment to ensuring compliance and fostering innovation in drug development. Notably, he has managed regulatory strategies for CNS therapeutic areas and has a proven track record of successful FDA interactions. Paul is dedicated to advancing the field of pharmaceuticals through effective regulatory practices.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Industry-specific interests

Leadership Development

Organisational experience

Corporate Experience

Paul Kirsch

Work Experience

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Vice President, Regulatory Affairs at

Harmony Biosciences

October 2023 - Present

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Vice President, Regulatory Affairs and Quality Assurance at

Zynerba Pharmaceuticals

January 2020 - Present

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Vice President, Regulatory Affairs at

Trevena, Inc.

May 2017 - January 2020

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Vice President Regulatory Affairs at

Iroko Pharmaceuticals, Llc

July 2014 - May 2017

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Executive Director, Regulatory Affairs at

Iroko Pharmaceutical

May 2013 - June 2014

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Sr. Director and Group Leader, Regulatory Affairs at

Cephalon

August 1993 - April 2012

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Regulatory Affairs Coordinator at

Wyeth Ayerst

September 1983 - August 1993

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Paul Kirsch

Education

University of Scranton, Bachelor Of Science (B.S.)

January 1979 - January 1983

Frequently Asked Questions about Paul Kirsch

What is Paul Kirsch email address?

Paul Kirsch's primary email address is ****@zynerba.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Paul Kirsch work for?

Paul Kirsch is a Vice President, Regulatory Affairs at Harmony Biosciences, a company specializing in Pharmaceutical & Medicine Manufacturing.

Where Paul Kirsch graduated from?

Paul Kirsch holds a degree in Biology, General from University of Scranton.

How can I directly contact Paul Kirsch?

To contact Paul Kirsch directly, you can use the email address ****@zynerba.com. Complete contact information is available upon registration with Muraena.

Who is Paul Kirsch?

Paul Kirsch is a seasoned executive with extensive experience in Regulatory Affairs within the pharmaceutical industry. He currently serves as the Vice President of Regulatory Affairs at Harmony Biosciences, where he oversees regulatory strategies and submissions. With a career spanning over three decades, Paul has held leadership positions at various pharmaceutical companies, including Zynerba Pharmaceuticals and Trevena. His expertise encompasses both US and International Regulatory Affairs, with a strong focus on clinical development and drug registration. Paul is known for his strategic insight into health agency liaison activities and corporate due diligence. He holds a Bachelor of Science in Biology from the University of Scranton. His passion for the biopharmaceutical sector is evident in his commitment to ensuring compliance and fostering innovation in drug development. Notably, he has managed regulatory strategies for CNS therapeutic areas and has a proven track record of successful FDA interactions. Paul is dedicated to advancing the field of pharmaceuticals through effective regulatory practices.

Paul`s contact details

mail

****@zynerba.com

*******@cephalon.com

Colleagues

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Stephen Mollichella

Vice President, Controller

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Peter Anastasiou

Board Member

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Andrew Serafin

Chief Strategy Officer (CSO)

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George Nomikos

Vice President, Clinical Development & Strategy

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Ronald Mihalcean

Vice President of Manufacturing

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Michael Farrell

Executive Director, Finance

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Michele Kemp

Executive Director, Consumer Marketing

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Kumar Budur

Chief Medical and Scientific Officer

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Mike Kenville

Vice President Quality Assurance

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