Kristina Cutter has extensive experience in regulatory affairs and pharmacovigilance, spanning across multiple companies in the pharmaceutical and biotechnology industry. Kristina started their career at Pfizer Inc. in 2002 as Director of U.S. Regulatory Affairs, where they supported the commercial oncology division. Kristina then moved on to InterMune Inc. as Sr. Director of Regulatory Affairs from 2005 to 2008. From 2008 to 2013, Kristina worked at Amgen, first as Director of Therapeutic Area Lead - Regulatory Promotion, and later as Executive Director of Commercial Regulatory, leading a team of 30+ staff.
In 2013, they joined Roche as Senior Director and Franchise Head of Global Regulatory Affairs, responsible for the regulatory strategy of pipeline candidates and commercial products in ophthalmology and respiratory franchises. Kristina then worked at DIA in 2015 as VP Regulatory & Safety, before joining Halozyme Therapeutics, Inc. as Vice President from 2015 to 2020.
Most recently, Kristina has been working at Alector since 2019, holding various roles including Chief Regulatory, Pharmacovigilance & Quality Officer, Senior Vice President of Regulatory Affairs, Pharmacovigilance & Quality Assurance, and Vice President of Regulatory Affairs and Pharmacovigilance. Their roles at Alector involved driving the mission and vision of the company, leading a dynamic team, and developing and delivering Alector's portfolio.
Overall, Kristina Cutter has demonstrated expertise in regulatory affairs, pharmacovigilance, and quality assurance throughout their career, making significant contributions to the development and commercialization of pharmaceutical products.
From 1994 to 1996, Kristina Cutter attended the University of Michigan, where they obtained a Master of Public Health degree with a focus on Nutrition Education. This is the only education history provided for her.
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