Toni Marie Nearing

Principal Regulatory Strategist @Quantum Regulatory Solutions, Llc

Kalamazoo, MI, US

My career spans over 37 years of regulatory experience:(19 yrs) years as Senior Director in Global Regulatory Affairs within Contract Research Organizations (CROs),(13) years at the FDA in regulatory affairs and legislative policy, primarily with the Center for Drug Evaluation and Research [including (2) years in the Center for Biologics Evaluation and Research], and (5) years of industry experience as Director of Regulatory Affairs in mid-size and large pharma. A key focus of my efforts has been in the development of regulatory strategy from proof of concept through successful product registration, launch, and lifecycle management. This has resulted in a successful registration track record, including 505(b)(1) and 505(b)(2) applications, and a biologics marketing application. I have been involved in pre- and post- marketing global strategies across numerous therapeutic areas such as (but not limited to): Oncology, Dermatology, Antivirals, Antidepressants and Antipsychotics. I hold a Bachelor of Sciences degree with the University of Maryland, College Park, and have received numerous awards at the FDA and in the industry.

University of Maryland

B.S., Biology & Chemistry Secondary Education

Academy of the Holy Cross Kensington MD

High School Diploma