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Sandra Suarez-Sharp
Sandra Suarez-Sharp
President, Regulatory Strategies | Simulations Plus, Inc.
Maryland, United States
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.
Sandra Suarez-Sharp
Work Experience
President, Regulatory Strategies at
Simulations Plus, Inc.
January 2024 - Present
Vice President Regulatory Affairs at
Simulations Plus, Inc.
March 2020 - December 2023
Scientific Advisor to the Division of Biopharmaceutics at
FDA
October 2019 - February 2020
Master Biopharmaceutics Reviewer at
FDA
March 2014 - September 2019
Senior Biopharmaceutics Reviewer at
FDA
August 2009 - February 2014
Senior Clinical Pharmacology Reviewer - Division of Pulmonary & Allergy Products at
FDA
October 2007 - July 2009
Senior Clinical Pharmacology Reviewer - Division of Reproductive & Urologic Products at
FDA
February 2006 - October 2007
Bioequivalence Reviewer - Division of Bioequivalence at the Office of Generic Drugs at
FDA
July 2005 - July 2006
Clinical Pharmacology and Biopharmaceutics Reviewer - Division of Pulmonary & Allergy Drug Products at
FDA
August 2000 - June 2005
Clinical Pharmacology and Biopharmaceutics Reviewer - Division of Antiviral Drugs at
FDA
September 1999 - August 2000
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
******@simulations-plus.com
Colleagues
Chief Executive Officer
Executive Vice President
Associate Vice President, Software Business Development
Associate Vice President, Global Head of Business Development, Services
Executive Director
Executive Director Human Resources
Executive Director of Operations
VP, PBPK Product Development
Vice President, Business Integration and Transformation
President, Clinical Pharmacology & Pharmacometrics Services at Simulations Plus, Inc