- Company: Regulatory Affairs, North America, Inc.
- Phone: 919 949 4617
- Website: www.ranainc.com
Specialties & Experience
General Specialties: Pharmaceutical Regulation
Specialty Focus: FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration,regulatory affairs practice, FDA regulated industry, submissions/dossiers,labeling, compliance.
Education: M.S., Florida State University; B.A. , Woman's College University of North Carolina
Years in Practice: 35+
Number of Times Deposed/Testified in Last 4 Yrs: 1
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs. Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters. Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields. Member of the Scientific Advisory Board for BioLink Sciences, Inc. Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professionals Society (RAPS). Co-creator of the Regulatory Affairs Professionals Society’s regulatory affairs credentialing (RAC)program. Recipient of the Richard E. Greco Regulatory Affairs Professional Award, and the Leonard J. Stauffer Award for Mentoring, Regulatory Affairs Professional Society. Past chair of the Regulatory Affairs Professional Society credentialing board. Past Vice President of Education and Membership for the Regulatory Affairs Professional Society. Past president of the North Carolina Regulatory Affairs Forum. Fellowships Completed: o Predoctoral fellowship in Biochemistry from Cornell University Medical College. o Public Health Service predoctoral fellowship from the National Institute of General Medical Sciences at Florida State University. o Florida State University Teaching Fellowship