Michelle Wells
Senior Director Regulatory Affairs at Corcept Therapeutics | Menlo Park, California, United States
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Michelle Wells is a seasoned Regulatory Affairs professional currently serving as the Senior Director of Regulatory Affairs at Corcept Therapeutics. With over 25 years of extensive experience in the regulatory landscape for drugs, devices, and biologics, Michelle has honed her expertise in navigating complex regulatory submissions, particularly in the realm of inhalation drugs and devices, vascular grafts, and a wide array of therapeutic formulations including creams, ointments, and diagnostic drugs.
At Corcept, a leader in the development of selective glucocorticoid receptor antagonists, Michelle plays a pivotal role in advancing the company’s mission to address cortisol dysregulation, which is linked to numerous endocrine, metabolic, oncologic, psychiatric, and ophthalmologic conditions. Her leadership is instrumental in guiding key projects that involve the regulatory strategy for innovative therapies aimed at improving patient outcomes. Michelle’s proficiency in quality systems, including ISO 13485, and her comprehensive understanding of FDA regulations enable her to ensure compliance while fostering a culture of quality and excellence within the organization.
Her strategic vision and ability to lead cross-functional teams have been critical in the successful navigation of regulatory pathways, facilitating timely submissions and approvals. As a Regulatory Affairs Certified (RAC) professional, Michelle is not only adept at managing the intricacies of regulatory frameworks but also passionate about mentoring the next generation of regulatory professionals. Her commitment to quality auditing and design control further underscores her dedication to maintaining the highest standards in the biotechnology and life sciences sectors, making her an invaluable asset to Corcept Therapeutics and the broader healthcare community.
Senior Director Regulatory Affairs at Corcept Therapeutics in October 2022 to April 2025
Vice President Regulatory Affairs at Frequency Therapeutics in February 2019 to April 2022
Director Regulatory Affairs at Sangamo Therapeutics, Inc. in July 2017 to October 2018
Instructor, Clinical Research and Regulatory Affairs at Keck Graduate Institute in January 2016 to June 2017
Regulatory Affairs Director at AmnioTechnology in August 2014 to July 2015
MSF Rider Coach at T.E.A.M. Motorcyclist Training Centers, Motorcycle Safety Foundation in January 2006 to January 2015
Regulatory Affairs at W.L. Gore and Associates in March 2007 to July 2014
Associate Director, Regulatory Affairs at Medicis in January 2002 to January 2007
Manager, QA/RA Compliance at The Tech Group in January 2001 to January 2002
Manager, Application Compliance; Specialist at Schein/Watson Pharmaceuticals in January 1996 to January 2001
Regulatory Affairs Specialist at CR Bard in January 1997 to January 1998
Regulatory Affairs Associate at DEY Laboratories in January 1989 to January 1996
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CMC
IND
Standard Operating Procedure (SOP)
Organizational Leadership
Market Research
Quality Assurance
Auditing
Public Speaking
Leadership
Management
Topical Medication
GMP
Regulatory Requirements
R&D
Regulatory Affairs
ANDA
Medical Devices
FDA
NDA
Quality Auditing
CAPA
Quality System
Regulatory Submissions
ISO 13485
Lifesciences
Strategy
Validation
Design Control
Pharmaceutical Industry
Pharmaceutics
Clinical Trials
Life Sciences
Biotechnology
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Research and Development (R&D)
New Drug Application (NDA)
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Discover more about Corcept TherapeuticsWhat is Michelle Wells email address?
Email Michelle Wells at [email protected]. This email is the most updated Michelle Wells email found in 2026.
What is Michelle Wells phone number?
Michelle Wells phone number is +19282255552.
How to contact Michelle Wells?
To contact Michelle Wells send an email to [email protected]. If you want to call Michelle Wells try calling on +19282255552. (updated on October 29, 2024)
What company does Michelle Wells work for?
Michelle Wells works for Corcept Therapeutics
What is Michelle Wells's role at Corcept Therapeutics?
Michelle Wells is Senior Director Regulatory Affairs
What industry does Michelle Wells work in?
Michelle Wells works in the Software Development industry.
Michelle Wells Email Addresses
Michelle Wells Phone Numbers
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