Experience

Association for Accessible Medicines

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vice President, Science and Regulatory Affairs

  • Jun 2022 - Present

  Washington, District of Columbia, United States In my role, I support the members of the Association for Accessible Medicines (AAM), the trade association representing the makers of generic and biosimilar medicines. AAM works to ensure more generic and biosimilar medicines are more accessible to more people who need them. The science and regulatory affairs team serves as AAM’s primary liaison with the FDA. We negotiate user fee agreements (i.e., GDUFA and BsUFA) and facilitate the implementation of new changes in subsequent agreements. We… Show more In my role, I support the members of the Association for Accessible Medicines (AAM), the trade association representing the makers of generic and biosimilar medicines. AAM works to ensure more generic and biosimilar medicines are more accessible to more people who need them. The science and regulatory affairs team serves as AAM’s primary liaison with the FDA. We negotiate user fee agreements (i.e., GDUFA and BsUFA) and facilitate the implementation of new changes in subsequent agreements. We work with our members to shape guidance, policies and practices the FDA develops impacting our industry. Additionally, we work alongside our government affairs and policy colleagues to help connect the dots between proposed and new legislation to the day-to-day activities of manufacturers and assess the impact of newly proposed laws. We strive to ensure generic and biosimilars manufacturers can develop and deliver medicines to all patients. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Global Regulatory & Development Policy

  • Sep 2019 - Jun 2022

  Rockville, MD



FDA Office of Pharmaceutical Quality/Office of New Drugs Products

• Office Director (acting)

  • Feb 2018 - Sep 2019

  Silver Spring



FDA Office of Pharmaceutical Quality/Office of Program of Regulatory Operations

• Office Director

  • Jan 2015 - Sep 2019

  Silver Spring, MD

• Office Director (Acting)

  • Jan 2015 - Aug 2016

  Silver Spring, MD



Food and Drug Administration (FDA)

• Regulatory Scientist

  • Mar 2010 - Jan 2015



Food and Drug Administration

• Project Management Officer

  • Oct 2007 - Mar 2010



FDA

• United States
• Government Administration
• 700 & Above Employee

• Regulatory Project Manager

  • Jan 2005 - Oct 2007