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Nicole Hsu

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Nicole Hsu

Vice President Regulatory Affairs | Obsidian Therapeutics

California, United States

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Nicole Hsu

Summary

Nicole Hsu is a seasoned professional in the biotechnology sector, currently serving as the Head of Regulatory Affairs at Obsidian Therapeutics. With over a decade of experience in regulatory affairs, she has held various leadership positions across multiple organizations, demonstrating a strong commitment to advancing clinical research and compliance. Her extensive expertise encompasses cell therapy, clinical trials, and regulatory submissions, particularly within the pharmaceutical industry. Nicole's educational background includes a Master's degree in Regulatory Science from the University of Southern California and a Bachelor's in Pharmacy from the University of Toronto. She is known for her strategic thinking and ability to navigate complex regulatory landscapes, making significant contributions to the development of innovative therapies. Outside of her professional endeavors, Nicole is passionate about mentoring the next generation of regulatory professionals and advocating for sustainable practices within the industry.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

Nicole Hsu

Work Experience

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Vice President Regulatory Affairs at

Obsidian Therapeutics

September 2021 - Present

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Senior Director, Regulatory Affairs at

Elicio Therapeutics

August 2020 - August 2021

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Director of Regulatory Affairs at

Aadi Bioscience

January 2019 - August 2020

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Associate Director Regulatory Affairs at

Atara Biotherapeutics

January 2017 - January 2019

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Senior Manager Regulatory Affairs at

Atara Biotherapeutics

April 2015 - January 2017

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Manager Regulatory Affairs at

Amgen

March 2015 - April 2015

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Sr. Associate Regulatory Affairs at

Amgen

April 2012 - March 2015

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Regulatory Affairs Graduate Intern (Diabetes) at

Medtronic

October 2011 - January 2012

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Regulatory Affairs Graduate Intern (Oncology) at

Amgen

June 2011 - August 2011

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Retail Pharmacist at

Rxrelief

August 2005 - August 2009

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Nicole Hsu

Education

University of Southern California, Msc

January 2010 - January 2012

University of Toronto, B.Scphm

January 2001 - January 2005

Frequently Asked Questions about Nicole Hsu

What is Nicole Hsu email address?

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

What company does Nicole Hsu work for?

Nicole Hsu is a Vice President Regulatory Affairs at Obsidian Therapeutics, a company specializing in Commercial physical research.

Where Nicole Hsu graduated from?

Nicole Hsu holds a degree in Regulatory Science from University of Southern California.

How can I directly contact Nicole Hsu?

To contact Nicole Hsu directly, you can use the email address ****@obsidiantx.com. Complete contact information is available upon registration with Muraena.

Who is Nicole Hsu?

Nicole Hsu is a seasoned professional in the biotechnology sector, currently serving as the Head of Regulatory Affairs at Obsidian Therapeutics. With over a decade of experience in regulatory affairs, she has held various leadership positions across multiple organizations, demonstrating a strong commitment to advancing clinical research and compliance. Her extensive expertise encompasses cell therapy, clinical trials, and regulatory submissions, particularly within the pharmaceutical industry. Nicole's educational background includes a Master's degree in Regulatory Science from the University of Southern California and a Bachelor's in Pharmacy from the University of Toronto. She is known for her strategic thinking and ability to navigate complex regulatory landscapes, making significant contributions to the development of innovative therapies. Outside of her professional endeavors, Nicole is passionate about mentoring the next generation of regulatory professionals and advocating for sustainable practices within the industry.

Nicole`s contact details

mail

****@obsidiantx.com

Colleagues

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Gwen Wilmes

Vice President, Analytical Development

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Michelle Ols

Vice President, Head of Cell Therapy

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Nic Betts

Vice President of IT and Facilities

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Giri Ramsingh

Vice President Clinical Sciences

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Chirag Khatiwala

Vice President - Process Development and Manufacturing

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James Kang

Vice President, Head of Intellectual Property

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Jennifer Peterson

Chief People Officer

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Madan Jagasia

Chief Executive Officer

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Prakash Prabhakar

Vice President, Clinical Operations & Translational Early Clinical Development

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