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...
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.
