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Sandra Suarez-Sharp

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Sandra Suarez-Sharp

President, Regulatory Strategies | Simulations Plus, Inc.

Maryland, United States

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Sandra Suarez-Sharp

Summary

Sandra Suarez-Sharp is a seasoned regulatory expert with over 20 years of experience at the FDA, specializing in biopharmaceutics and regulatory strategies. As the President of Regulatory Strategies at Simulations Plus, she leads a team dedicated to assisting pharmaceutical companies in navigating complex global regulatory landscapes. Her innovative approach focuses on patient-centric drug development, aiming to streamline regulatory processes and reduce costs. Sandra's extensive background includes significant roles at the FDA, where she contributed to the advancement of drug approval processes. She is also recognized for her mentoring and communication skills, evidenced by multiple awards throughout her career. Sandra is passionate about fostering collaboration within the industry, as demonstrated by her active participation in professional groups. Her academic credentials include a Ph.D. in Pharmaceutical Sciences from the University of Florida, further solidifying her authority in the field.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

Government Experience

Sandra Suarez-Sharp

Work Experience

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President, Regulatory Strategies at

Simulations Plus, Inc.

January 2024 - Present

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Vice President Regulatory Affairs at

Simulations Plus, Inc.

March 2020 - December 2023

company logo

Scientific Advisor to the Division of Biopharmaceutics at

FDA

October 2019 - February 2020

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Master Biopharmaceutics Reviewer at

FDA

March 2014 - September 2019

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Senior Biopharmaceutics Reviewer at

FDA

August 2009 - February 2014

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Senior Clinical Pharmacology Reviewer - Division of Pulmonary & Allergy Products at

FDA

October 2007 - July 2009

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Senior Clinical Pharmacology Reviewer - Division of Reproductive & Urologic Products at

FDA

February 2006 - October 2007

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Bioequivalence Reviewer - Division of Bioequivalence at the Office of Generic Drugs at

FDA

July 2005 - July 2006

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Clinical Pharmacology and Biopharmaceutics Reviewer - Division of Pulmonary & Allergy Drug Products at

FDA

August 2000 - June 2005

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Clinical Pharmacology and Biopharmaceutics Reviewer - Division of Antiviral Drugs at

FDA

September 1999 - August 2000

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Sandra Suarez-Sharp

Education

University of North Carolina at Chapel Hill, Post-Doctoral Fellow

January 1997 - January 1999

University of Florida, Graduate Student Ph.D. Program

January 1994 - January 1997

University of Florida, Ph.D.

January 1997

Frequently Asked Questions about Sandra Suarez-Sharp

What is Sandra Suarez-Sharp email address?

Sandra Suarez-Sharp's primary email address is ******@simulations-plus.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Sandra Suarez-Sharp work for?

Sandra Suarez-Sharp is a President, Regulatory Strategies at Simulations Plus, Inc., a company specializing in Computer terminals.

Where Sandra Suarez-Sharp graduated from?

Sandra Suarez-Sharp holds a degree in Department Of Pharmaceutics from University of North Carolina at Chapel Hill.

How can I directly contact Sandra Suarez-Sharp?

To contact Sandra Suarez-Sharp directly, you can use the email address ******@simulations-plus.com. Complete contact information is available upon registration with Muraena.

Who is Sandra Suarez-Sharp?

Sandra Suarez-Sharp is a seasoned regulatory expert with over 20 years of experience at the FDA, specializing in biopharmaceutics and regulatory strategies. As the President of Regulatory Strategies at Simulations Plus, she leads a team dedicated to assisting pharmaceutical companies in navigating complex global regulatory landscapes. Her innovative approach focuses on patient-centric drug development, aiming to streamline regulatory processes and reduce costs. Sandra's extensive background includes significant roles at the FDA, where she contributed to the advancement of drug approval processes. She is also recognized for her mentoring and communication skills, evidenced by multiple awards throughout her career. Sandra is passionate about fostering collaboration within the industry, as demonstrated by her active participation in professional groups. Her academic credentials include a Ph.D. in Pharmaceutical Sciences from the University of Florida, further solidifying her authority in the field.

Sandra`s contact details

mail

******@simulations-plus.com

Colleagues

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Shawn Oconnor

Chief Executive Officer

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Ted Grasela

Executive Vice President

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Peter Kilford

Associate Vice President, Software Business Development

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Gary Kusha

Associate Vice President, Global Head of Business Development, Services

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Grace Fraczkiewicz

Executive Director

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Lindsay Luke Shrm-Cp

Executive Director Human Resources

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Lisa Behr

Executive Director of Operations

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Neil Miller

VP, PBPK Product Development

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Julie Cook Cpa

Vice President, Business Integration and Transformation

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Jill Fiedler-Kelly

President, Clinical Pharmacology & Pharmacometrics Services at Simulations Plus, Inc

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