Meredith Sewell
VP, Regulatory Operations at Sarepta Therapeutics | Irvine, California, United States
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Meredith Sewell serves as the Vice President of Regulatory Operations at Sarepta Therapeutics, where she plays a pivotal role in advancing the company's mission to develop innovative therapies for rare diseases. With a strong focus on regulatory submissions and compliance, Meredith leads multiple teams, including Medical Writing, Trial Master File (TMF) management, and Advertising & Promotional Labeling. Her expertise in regulatory affairs and deep understanding of the pharmaceutical industry enable her to navigate the complexities of FDA regulations and ensure that all documentation meets the stringent requirements set forth by the U.S. Food and Drug Administration (FDA).
Under her leadership, Sarepta has embarked on transformative cloud-based harmonization projects that streamline regulatory processes and enhance collaboration across cross-functional teams. Meredith’s commitment to process optimization not only improves efficiency but also fosters a culture of transparency and accountability within her teams. She is adept at mentoring global teams, empowering them to excel in their roles while aligning their efforts with the company's strategic objectives, particularly during critical phases of mergers and acquisitions.
Meredith's extensive background in clinical trials and document management, coupled with her proficiency in U.S. Title 21 CFR Part 11 regulations, positions her as a thought leader in the biotechnology sector. Her ability to craft and implement Standard Operating Procedures (SOPs) ensures that Sarepta maintains the highest standards of quality and compliance throughout the regulatory lifecycle. As she continues to drive innovation and excellence in regulatory operations, Meredith Sewell remains a key figure in shaping the future of therapeutic development at Sarepta Therapeutics.
VP, Regulatory Operations at Sarepta Therapeutics in October 2022 to Present
Executive Director, Global Regulatory Operations at Sarepta Therapeutics in November 2020 to October 2022
President at Novalink Consulting LLC in July 2020 to November 2020
Executive Director, Global Regulatory Submissions at Allergan in March 2017 to November 2020
Director, Global Regulatory Publishing at Allergan in February 2011 to March 2017
Associate Director, Global Regulatory Affairs Publishing at Allergan in March 2006 to April 2011
Manager, Regulatory Affairs at Amgen in September 2004 to February 2006
Associate Manager, Regulatory Affairs Publishing at Amgen in September 2003 to August 2004
Supervisor, Regulatory Affairs Publishing at Amgen in August 2001 to September 2003
Associate II at Amgen in July 2000 to August 2001
Associate I at Amgen in June 1998 to July 2000
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UC Irvine, Bachelor of Arts - BA
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Regulatory Submissions
Regulatory Affairs
eCTD
Pharmaceutical Industry
FDA
Sop
Documentum
Clinical Trials
IND
Biotechnology
GCP
Regulatory Requirements
21 CFR Part 11
CTMS
Clinical Development
Document Management
Drug Development
Pharmacovigilance
SOP
Electronic Common Technical Document (eCTD)
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
U.S. Title 21 CFR Part 11 Regulation
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Discover more about Sarepta TherapeuticsWhat is Meredith Sewell email address?
Email Meredith Sewell at [email protected]. This email is the most updated Meredith Sewell's email found in 2026.
How to contact Meredith Sewell?
To contact Meredith Sewell send an email to [email protected]. (updated on January 18, 2024)
What company does Meredith Sewell work for?
Meredith Sewell works for Sarepta Therapeutics
What is Meredith Sewell's role at Sarepta Therapeutics?
Meredith Sewell is VP, Regulatory Operations
What is Meredith Sewell's Phone Number?
Meredith Sewell's phone (213) ***-*254
What industry does Meredith Sewell work in?
Meredith Sewell works in the Pharmaceuticals industry.
Meredith Sewell Email Addresses
Meredith Sewell Phone Numbers
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