Rich Rolke is an CMC Associate Vice President in the Pharmaceutical Post-Approval Products team within Merck’s Global Regulatory Affairs Clinical and Safety division. He currently manages several small molecule CMC teams within the organization supporting a large portfolio of Top 40 and Diversified Products along with having accountabilities for CMC Sourcing and Project Management.
Rich has a diverse pharmaceutical industry background with experience in formulation/process development, scale-up, technology transfer, process validation and significant global post-approval CMC expertise including agency interactions with US FDA, Health Canada and European regulatory authorities.
Prior to joining Merck, Rich led a large post-approval CMC team comprised of internal and outsourced resources within Pfizer. Rich was certified as a Six Sigma Black Belt and has led a variety of process improvement initiatives. Before moving into CMC, Rich held positions in product and process development at Pfizer, Johnson & Johnson (McNeil Consumer and Specialty Pharmaceuticals), Wyeth (ESI/Lederle) and Whitehall Robbins.
Rich holds a degrees in Chemistry and Environmental Sciences from Stockton College, a Master of Science in Chemistry from Drexel University and a Master of Business Administration from LaSalle University.
