Vice President of Global Regulatory Affairs & Quality Assurance
Mark A. Mannebach, Ph.D., R.Ph., joined Charleston Laboratories as its Vice President of Global Regulatory Affairs & Quality Assurance. In his role, Mark will work with the executive team to develop and maintain the global regulatory strategy within alignment of the company’s global strategy. Mark will oversee and manage all regulatory submissions and renewals and will be responsible for developing the technical requirements of supply and Quality agreements and other external contracts. Mark has more than 30 years of experience in the Pharmaceutical Industry in a variety of leadership roles at various major pharmaceutical companies including Parke-Davis/Warner-Lambert, Pharmacia, Baxter and Pfizer. For the past 8 years, Mark was the Vice President of Global Regulatory Affairs at Mallinckrodt where he spent a significant amount of his time overseeing the pain management portfolio. Mark has extensive experience working with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) on a number of NDAs including 505(b)(2) applications. New approved pain products that Mark has worked on include Exalgo, Pennsaid (both 1.5% & 2% topical solutions), Xartemis XR, and Ofirmev.