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James Burgess has a comprehensive work history in the field of regulatory affairs. James currently holds the position of Senior Director, Regulatory Affairs Strategy at SK Life Science, Inc., a role they have been in since April 2023. Before this, they were the Director, Regulatory Affairs Strategy at the same company from May 2021 to March 2023.

Prior to joining SK Life Science, Inc., James worked at Mallinckrodt Pharmaceuticals as the Director, Global Regulatory Lead from July 2020 to May 2021. In this role, they were responsible for developing and implementing regulatory strategies, managing the Global Regulatory Product Team, and leading the successful NDA submission and Advisory Committee meeting for Terlivaz (Terlipressin). James also served as the Associate Director, Global Regulatory Lead from August 2016 to July 2020, where they developed regulatory strategies for post-approval and life cycle management on assigned programs.

Before their time at Mallinckrodt Pharmaceuticals, James worked at Colgate Palmolive as a Regulatory Affairs Manager from June 2015 to July 2016. Prior to that, they held positions at RB as a Global Regulatory Lead from August 2013 to May 2015 and as a Regulatory CMC Lead from March 2011 to July 2013.

James began their career at Novartis Consumer Health, where they served as a Quality Assurance Manager from August 2005 to March 2011 and as a Senior Quality Assurance Lead in R&D from June 2002 to August 2005. James also has experience as a Manufacturing Supervisor at schering plough from 1997 to 2002.

Throughout their career, James has demonstrated expertise in developing and implementing regulatory strategies, managing regulatory teams, leading successful NDA submissions and Advisory Committee meetings, and ensuring compliance with regulatory requirements.

James Burgess attended Purdue University from 1992 to 1997, where they obtained a BS degree in Pharmacy.