James Bammert, Pharm.D.
Director, Regulatory Strategy
James Bammert has over twenty years of experience in the pharmaceutical industry, with 16 years in Regulatory Affairs. Jim began his career in industry at Warner Lambert/Parke Davis in Clinical Pharmacy Operations. From there, he transitioned to Regulatory Affairs and has held positions of increasing levels of responsibility. He has experience working for two major pharmaceutical companies (Warner Lambert/Pfizer and EMD Serono). In these roles he has provided regulatory guidance and strategic direction to project teams both locally and as a global Regulatory Lead. He has experience that ranges from early development (i.e. clinical trials applications in US/EU/Canada) to post-approval support for marketed products. Jim has supported development of both biologics and small molecules and has broad therapeutic area expertise including neurology, rheumatology/immunology, pain, anti-inflammatory, allergy, asthma (inhalers), dermatology, and erectile dysfunction. In addition, Jim has provided leadership for numerous FDA meetings, and licensing activities.
Jim completed his initial pharmacy training (BS) at Wayne State University in Detroit, MI. He subsequently completed his doctoral training in Pharmacy at the University of Florida.