Meredith Sewell Email & Phone Number

Meredith Sewell

VP, Regulatory Operations at Sarepta Therapeutics | Irvine, California, United States

Meredith Sewell Socials
About Meredith Sewell

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.

Meredith Sewell Work
1 experience icon

VP, Regulatory Operations at Sarepta Therapeutics in October 2022 to Present

2 experience icon

Executive Director, Global Regulatory Operations at Sarepta Therapeutics in November 2020 to October 2022

3 experience icon

President at Novalink Consulting LLC in July 2020 to November 2020

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Meredith Sewell Education

UC Irvine, Bachelor of Arts - BA

Meredith Sewell Skills

Regulatory Submissions

Regulatory Affairs

eCTD

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About Meredith Sewell's Current Company
Frequently Asked Questions about Meredith Sewell

What 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

Email Meredith Sewell at [email protected]. This email is the most updated Meredith Sewell's email found in 2026.

Meredith Sewell Phone Numbers

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