Sherry Condie, Rac
About Sherry Condie, Rac
Sherry Condie is a Senior Manager in CMC Regulatory Affairs with over eight years of experience in regulatory affairs, focusing on small molecules and biologics. She currently works at Mirum Pharmaceuticals and has held various positions in regulatory roles at companies such as Regeneron and Rhodes Pharmaceuticals.
Current Role at Mirum Pharmaceuticals
Sherry Condie serves as the Senior Manager of CMC Regulatory Affairs at Mirum Pharmaceuticals. She has held this position since 2021 and is based in New York, United States. In her role, she leads or supports interactions with Health Authorities and provides regulatory support on technical and quality activities. This includes overseeing manufacturing process development and change control management. Condie actively seeks knowledge of corporate planning and factors affecting regulatory positions to enhance submission planning.
Previous Experience in Regulatory Affairs
Prior to her current role, Sherry Condie accumulated extensive experience in regulatory affairs. She worked at Regeneron as a Senior CMC Regulatory Sciences Specialist from 2017 to 2021. Before that, she held positions at Rhodes Pharmaceuticals, first as a Regulatory Affairs Analyst II from 2015 to 2016, and then as a Regulatory Affairs Associate from 2016 to 2017. Her experience spans over eight years, focusing on both small molecules and biologics.
Educational Background in Biochemistry
Sherry Condie earned her Bachelor's Degree in Biochemistry from Elmira College, where she studied from 2008 to 2012. This educational background provided her with a strong foundation in the scientific principles that underpin her work in regulatory affairs.
Regulatory Affairs Skills and Expertise
Sherry Condie's expertise in regulatory affairs includes ensuring that CMC dossiers comply with ICH and country-specific requirements. She is involved in authoring meeting requests, briefing documents, and responses to health authority inquiries. Additionally, she manages and maintains the regulatory CMC tracker and related documents, demonstrating her organizational skills and attention to detail.
Early Career Experience
Sherry Condie's early career included a role as a Laboratory Technician at Genex Cooperative, Inc. and Cooperative Resources International from 2012 to 2013. This position provided her with practical laboratory experience, which complements her regulatory affairs expertise.