Pamela Munroe
About Pamela Munroe
Pamela Munroe is the Director and Head of Regulatory Operations and Project Management at Deciphera Pharmaceuticals, where she has worked since 2020. She has extensive experience in regulatory operations, particularly with the electronic Common Technical Document (eCTD) format, and has held various roles in the pharmaceutical industry over the past 18 years.
Work at Deciphera Pharmaceuticals
Pamela Munroe serves as the Director and Head of Regulatory Operations and Project Management at Deciphera Pharmaceuticals. She has held this position since 2020, contributing to the company's regulatory strategy and project management initiatives. Her role involves overseeing regulatory submissions and ensuring compliance with industry standards. Munroe's expertise in regulatory operations plays a critical role in advancing Deciphera's pharmaceutical projects.
Previous Experience in Regulatory Operations
Prior to her current role, Pamela Munroe accumulated extensive experience in regulatory operations across several pharmaceutical companies. She worked at Shire Pharmaceuticals as Manager of Global Regulatory Operations from 2010 to 2019, and at Kiniksa Pharmaceuticals as Senior Manager of Global Regulatory Operations for 11 months in 2019-2020. Additionally, she held positions at Genzyme and Cubist Pharmaceuticals, where she focused on electronic submissions and regulatory operations.
Education and Expertise
Pamela Munroe earned a Bachelor of Science degree in Psychology from Northeastern University. She possesses advanced expertise in the electronic Common Technical Document (eCTD) format and has extensive experience with eCTDXpress. Munroe is also proficient in using MS Word and Adobe Acrobat, including the Toolbox plugin, which supports her work in regulatory submissions.
Skills in Regulatory Submissions
Pamela Munroe has developed strong skills in managing regulatory submissions, demonstrating excellent organizational and time management abilities. She remains calm and focused under stress, which is essential for the successful handling of regulatory documentation. Her experience as a Vault Owner for Veeva Submissions Vault, along with her knowledge of Veeva Qualitydocs and PromoMats, further enhances her capabilities in this field.