Wayne Vallee, RPh, MBA, RAC

Director, Regulatory Affairs and Product Development

Wayne Vallee, RPh, MBA, RAC, is Director, Regulatory Affairs and Product Development for Cardinal Health Regulatory Sciences.

Role responsibilities

Vallee is responsible for a team of regulatory affairs and product development consultants who provide consulting services at all stages of drug development, from concept to New Drug Application (NDA) approval and maintenance.

Professional experience

Vallee has more than 32 years of experience in formulation development, project management and regulatory affairs. His experience includes allergy, oncology, neurology, psychiatry, dietary supplements and over-the-counter products. He also has extensive experience working with several different review divisions of the FDA as well as preparing for and leading FDA meetings.
Prior to joining Cardinal Health in 2003, Vallee was Director of Regulatory Affairs for Quintiles. He has also held manager and technical positions with Hoechst Marion Roussel Inc., Marion Merrill Dow, Marion Laboratories and Sterling Winthrop Research Institute.

Education

Vallee received a master’s degree in business administration from Russell Sage College and a bachelor’s degree in pharmacy from the Albany College of Pharmacy. Vallee is also a registered pharmacist in Missouri.

Areas of Expertise


FDA meetings

Regulatory affairs

Drug development and formulation

Quality assurance

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