Pam Wilson
About Pam Wilson
Pam Wilson is the Director of Regulatory Affairs at Alkermes in Wilmington, Ohio, with over 20 years of experience in research, development, and cGMP pharmaceutical/biotech manufacturing environments.
Company
Pam Wilson is currently working at Alkermes as the Director of Regulatory Affairs, based in Wilmington, Ohio. Alkermes is a biotech and pharmaceutical company that focuses on developing innovative therapies for the treatment of central nervous system (CNS) diseases, including addiction, schizophrenia, and depression.
Title
Pam Wilson holds the position of Director of Regulatory Affairs. In this role, she serves as an audit representative for the FDA, MHRA, and other Rest-Of-World (ROW) regulatory agencies. Her responsibilities include ensuring compliance with regulatory requirements and managing submissions to various health authorities.
Education and Expertise
Pam Wilson graduated from Miami University, where she earned a Bachelor of Science (BS) degree. She has over 20 years of experience in research, development, and Current Good Manufacturing Practice (cGMP) pharmaceutical and biotech manufacturing environments. Her expertise includes authoring and reviewing the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings, analytical QC lab management, and oversight of stability programs.
Background
Pam Wilson’s professional journey began as a Research Associate Pharmacologist at Marion Merrell Dow Research Institute, where she worked from 1988 to 1994. She then joined Alkermes and progressed through various roles over the years, including an Associate Director of QC Chemistry from 1995 to 2008 and Associate Director, RA-CMC from 2009 to 2020.
Experience in Regulatory Affairs
Pam Wilson has extensive experience in regulatory affairs, specializing in CMC regulatory requirements for submissions to FDA, EMA, PMDA, and other ROW Health Authorities. Her role includes leading specification committees, managing change control processes, conducting vendor audits, and vendor qualifications. She is also proficient in overseeing stability programs and ensuring compliance with regulatory standards.