Versatile Biologics Pharmaceuticals Professional with proven experience leading multi-discipline product development teams and global regulatory teams to deliver quality products for clinical evaluation and candidates for licensure. Known for building relationships, attention to regulatory detail, scientific expertise and innovative problem solving. Core competencies include: - Clinical trial and CMC regulatory guidance for biologics - Raw material, manufacturing and test deviation investigations - Quality global regulatory submissions - Manufacturing development experience

Director, Global Regulatory Strategy @ From January 2014 to Present (2 years) Senior Director Regulatory Affairs @ From February 2012 to November 2013 (1 year 10 months) Corvallis, Oregon AreaWorldwide Regulatory Affairs @ Held positions of increasing responsibility and complexity from Manager to Director within the Vaccines Regulatory Affairs Department. Guided bacterial and viral vaccine projects from early development through clinical trials to licensure in a Global Project Team and Global Regulatory Team environment. Managed up to 5 programs at once, including both development and licensed products, encompassing both clinical and CMC regulatory responsibilities. From 1999 to 2011 (12 years) Regulatory Affairs Professional @ From 1994 to 2009 (15 years) Senior Research Scientist, Wyeth Vaccines Development @ Developed scale-up strategies for cell culture, viral infection and antigen recovery for viral vaccine candidates. Developed serum-free cell banking system for Vero cells for use in clinical trial material manufacture. From 1994 to 1999 (5 years) Scienist II, Biochemical Product Division, Cell Biology @ Served as developer and manager for all activities of cGMP Cell Banking System servicing several divisions. Generated Master Cell Banks (MCB) and Manufacturer's Working Cell Banks (MWCB) under FDA regulations and ISO 9000. Set up the GMP cell banking system and laboratory from an existing R&D facility. Established new systems for equipment validation, calibration and environmental monitoring. From 1990 to 1994 (4 years) Indianapolis, Indiana AreaResearch Associate, Cell Banking and Characterization @ Generated Master Cell Banks and Manufacturer's Working Cell Banks with full characterization under the 1987 Points to Consider for the Manufacture of Biologicals from Cell Cultures and Monoclonal Antibodies. From 1988 to 1990 (2 years) Research Associate @ Provided cell culture and animal handling expertise for multiple Research Teams as part of a centralized Cell Culture facility and Biological Testing Facility. Moved into the Cardiovascular Research group as experience increased. From 1984 to 1988 (4 years) Immunochemist @ Prepared viral antigens produced from cell culture infections for use in test kits; encompassed viral infections, antigen isolation and purification and immunodiagnostic test kit development. From 1983 to 1984 (1 year)

BS, Microbiology @ San Jose State University From 1980 to 1983 Amy H. Nichols is skilled in: Regulatory Affairs, Regulatory Strategy, Regulatory Filings, eCTD, Vaccines, Clinical Trials, Clinical Development, GCP, Pharmaceuticals, Infectious Diseases, Biotechnology, cGMP, Product Development, FDA, Cell Culture