Margaret Wells
About Margaret Wells
Margaret Wells is the Associate Director of Global Regulatory CMC at Bristol-Myers Squibb with over 20 years of experience in the pharmaceutical industry, specializing in regulatory affairs and compliance.
Title
Margaret Wells is currently the Associate Director of Global Regulatory CMC at Bristol-Myers Squibb.
Company
Margaret Wells works at Bristol-Myers Squibb, a global biopharmaceutical company specializing in the discovery, development, and delivery of innovative medicines.
Previous Positions at Celgene
Margaret Wells has an extensive background at Celgene, where she served in various roles from 2005 to 2019. Her positions included Associate Director of Global Regulatory CMC, Senior Manager, Manager, Senior Manager of Software Quality Management, Manager of Software Quality Management, and Manager of Policies and Standards.
Previous Positions at Merck
Margaret Wells worked at Merck from 1997 to 2005. Her roles included Senior Regulatory Coordinator, Senior/GMP Compliance Associate, and Project Analyst. This experience provided her a solid foundation in regulatory affairs and compliance.
Education and Expertise
Margaret Wells holds a Master of Science from Columbia University - Fu Foundation School of Engineering and Applied Science. She also earned a Bachelor of Engineering from Manhattan College. She has over 20 years of experience in the pharmaceutical industry, focusing on regulatory affairs, compliance, and software quality management.
Regulatory Experience
Margaret Wells has a strong background in managing regulatory submissions and compliance for both small molecules and biologics. She played a key role in obtaining regulatory approvals for multiple high-profile drugs during her tenure at Celgene. Her experience also extends to developing and implementing regulatory strategies for global markets.
Leadership and Team Management
Margaret Wells has a proven track record of leading cross-functional teams to achieve regulatory milestones. Her leadership was instrumental in transitioning from software quality management to regulatory CMC, and she has consistently demonstrated the ability to guide teams toward successful regulatory outcomes.