Simone Cummings

Background

About Simone Cummings

I am a highly motivated, results-driven professional leader with over 17 years of experience in the FDA and EPA-regulated biotechnology industry. I thrive in fast-paced environments, able to adapt quickly to business changes and energized by new responsibilities. As a strategic thinker, I have a proven track record of driving change, fostering continuous improvement, and successfully navigating complex challenges. My professional goals include continued growth into leadership roles, further development of global regulatory manager/strategist expertise, staying ahead of the evolving regulatory landscape, expanding in project/program management, and enhancing business strategy skills. I am committed to assessing timelines and business risks to create and execute business strategies for the successful launch of innovative products. I am an active member of the Analytical Excellence through Industry Collaboration (AEIC) organization and the American Oil Chemists Society. Additionally, I am credited with a granted patent and publications, showcasing my contributions to innovation and the scientific community within the biotechnology field. Specialties: Project Management (PMP), Change Management, GLP, Pharmacokinetic and Pharmacodynamic Bioanalytical Methods, Immunogenicity, New Product R&D, Biotechnology, Protein Chemistry, Business Strategy, Regulatory Affairs.