Craig Audet
Independent Consultant at WRS Regulatory Consultants, LLC | South Yarmouth, Massachusetts, United States
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Dr. Craig Michael Audet, the founder of WRS Regulatory Consultants, LLC, brings over 37 years of invaluable experience in the global pharmaceutical and biotechnology sectors, with a particular focus on regulatory strategy and submission development. As an Independent Consultant, Dr. Audet leverages his extensive expertise to guide emerging life science companies through the complex landscape of drug development, from early-stage research to late-stage clinical trials. His strategic insights are instrumental in navigating the regulatory intricacies associated with Investigational New Drug (IND) applications, IND amendments, and Special Designation requests, including Fast Track, Breakthrough Therapy, and Orphan Drug Designations.
At WRS Regulatory Consultants, Dr. Audet is dedicated to developing and managing the strategic content of meeting materials that facilitate productive interactions with regulatory agencies. His proficiency in clinical research and regulatory submissions, particularly in therapeutic areas such as oncology and infectious diseases, positions him as a trusted advisor for companies seeking to optimize their development pathways. Dr. Audet’s comprehensive understanding of Good Clinical Practice (GCP) and investor relations further enhances his ability to communicate effectively with stakeholders, ensuring that clients are well-prepared to meet both regulatory expectations and market demands.
Through his leadership at WRS Regulatory Consultants, Dr. Audet is committed to empowering life science innovators to bring their groundbreaking therapies to market, ultimately improving patient outcomes and advancing public health. His passion for fostering collaboration between regulatory bodies and industry players underscores his role as a pivotal figure in the pharmaceutical landscape.
Independent Consultant at WRS Regulatory Consultants, LLC in August 2019 to Present
Principal Consultant at Halloran Consulting Group, Inc. in September 2019 to August 2020
Sr. Vice President, Regulatory Affairs & Quality Assurance at Evofem Biosciences in March 2017 to October 2018
Sr. Vice President, Operations & Head of Global Regulatory Affairs/Executive Officer at Arena Pharmaceuticals in April 2011 to October 2016
Adjunct Associate Professor at Temple University in August 2002 to July 2012
President at Worldwide Regulatory Services in August 2010 to March 2011
VP, US Regulatory Affairs at sanofi-aventis in December 2003 to August 2010
Global Therapeutic Area Leader - CV Products at Pfizer Pharmaceuticals in March 1998 to December 2003
Director, Corporate Regulatory Affairs at United States Surgical Corporation in January 1997 to March 1998
Director, Worldwide Regulatory Affairs at Strato/Infusaid in December 1993 to January 1997
Manager, Regulatory Affairs at Bard Vascular Systems Division in September 1990 to December 1993
Regulatory Affairs Supervisor at Lubrx Products, Inc. in May 1986 to September 1990
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Pharmaceutical Industry
Clinical Development
Clinical Trials
Regulatory Affairs
Oncology
Clinical Research
Drug Development
Biotechnology
Lifesciences
Diabetes
Pharmacology
Regulatory Submissions
Infectious Diseases
FDA
Medical Writing
GCP
Drug Discovery
Therapeutic Areas
Immunology
Investor Relations
Corporate Communications
Business Alliances
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What is Craig Audet email address?
Email Craig Audet at [email protected] and [email protected]. This email is the most updated Craig Audet email found in 2026.
What is Craig Audet phone number?
Craig Audet phone number is +12034701615 and +12033139754.
How to contact Craig Audet?
To contact Craig Audet send an email to [email protected] or [email protected]. If you want to call Craig Audet try calling on +12034701615 and +12033139754. (updated on October 30, 2024)
What is Craig Audet net worth?
Craig Audet has an estimated net worth of $750,000 to $999,999
What company does Craig Audet work for?
Craig Audet works for WRS Regulatory Consultants, LLC
What is Craig Audet's role at WRS Regulatory Consultants, LLC?
Craig Audet is Independent Consultant
What industry does Craig Audet work in?
Craig Audet works in the Business Consulting And Services industry.
Craig Audet Email Addresses
Craig Audet Phone Numbers
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