Regulatory CMC Expert
Colin has over 25 years of experience in the pharmaceutical industry, primarily in regulatory affairs and project management. He began his career in Kalamazoo, Michigan at The Upjohn Company, where he remained employed with Pharmacia and Upjohn, Pharmacia Corporation, and Pfizer, Inc. After working in analytical methods development, then developing and managing a cGMP compliance program, Colin joined the CMC regulatory affairs group at Pharmacia. As a principal scientist Colin was responsible for providing regulatory CMC strategy and project management, and for preparing the registration documentation for new human health compounds for all phases of drug development. With increasing expertise in regulatory affairs, his level of responsibilities increased to include positions as a pharmaceutical development team leader and as a regulatory CMC group leader. In his subsequent position as Director of CMC regulatory affairs, Colin managed regulatory scientists in the preparation of CMC registration documentation, participated on global development teams, and spearheaded various initiatives for improving organizational performance and global quality standards.
After leaving Pfizer, Inc. in 2005, he gained additional experience in the generic pharmaceutical industry working as an associate director of regulatory affairs for Hospira, Inc. and The Perrigo Co.
Colin holds a Bachelor of Science degree in Chemistry from Miami University.