Ruth Collins joined the Company as a Senior Regulatory Affairs Associate in 2012 after 22 years of pharmaceutical experience as a chemist, technical writer, and regulatory affairs associate. She has a Bachelor of Science degree in Chemistry from Bob Jones University and a MBA from Loyola University in Chicago.
Ruth began her career as a chemist with Geneva Laboratories, a contract laboratory in Wisconsin. She has experience with several chromatographic techniques, reviewing new technology for implementation, and the IQ/OQ/PQ of new technologies. She then moved to IVAX Pharmaceuticals (eventually a subsidiary of Teva Pharmaceuticals USA) as a Technical Writer and eventually promoted to Manager of Analytical Services. While leading a group of 10 people including chemists and writers preparing laboratory documentation for submission, she interacted with several of the Regulatory Affairs groups at Teva. Ruth was asked to transfer to Regulatory Affairs to bring her chemistry knowledge to the department while learning the science of regulatory submission with the Agency.
Ruth obtained RAC certification in 2011 and maintains the certification through continuous classes and training. After moving to Sovereign Pharmaceuticals, Ruth continued to provide quality submission including 505(b)(2) NDAs and ANDAs. She was promoted to her current position as Manager in 2017 where she continues to ensure quality submissions and helping client’s plan regulatory strategies.
Current role