Kathryn Farmer

Associate Director, Regulatory Affairs - CMC

Mississauga, Ontario

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Phone: +1 905-364-7800 Ext. 226
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Kathryn Farmer is an Associate Director of Regulatory Affairs at Intrinsik Corp., where she leads the organization’s Regulatory CMC team. She began her career in pharmaceutical regulatory affairs in 2006 and expanded into regulatory consulting in 2011. Kathryn brings extensive experience guiding products at every stage of development, marketing and post‑approval in both Canada and the United States.

Drawing on a strong academic foundation in biologics and comprehensive expertise across all product types, she is skilled in authoring and reviewing CMC documentation, executing regulatory strategies, and navigating complex global requirements. Kathryn ensures the delivery of robust, compliant, and forward‑thinking CMC regulatory content that supports successful submissions and long‑term product lifecycle management.

Experience Highlights

Leads the preparation of detailed regulatory assessments and the development of CMC modules for small molecules and a broad spectrum of biologic products.
Provides strategic regulatory guidance on CMC and pharmaceutical development challenges.
Oversees the implementation of CMC submission strategies.
Managing timelines and submission content for regulatory filings for Canada and the US.

Education and Professional Qualifications

B.Sc. (Honours), Biology, Wilfrid Laurier University
Regulatory Affairs Certificate, Humber College
Regulatory Affairs Certification (Canada), Regulatory Affairs Professionals Society

Professional Affiliations

Canadian Association of Professionals in Regulatory Affairs (CAPRA)
Drug Information Association (DIA)
Pharmaceutical Sciences Group (PSG)
Regulatory Affairs Professionals Society (RAPS)

Join Our Team

Intrinsik Corp., is a dynamic science-based consulting firm. We are eagerly interested in professionals to add to our accredited staff base. Intrinsik is strongly committed to our employees by ensuring mentoring, training and advancement for those with a drive to succeed. Our areas of expertise include and are not limited to toxicology, human health and environmental risk assessment, biology, multi-media exposure modeling, environmental science, and risk management.

Diversity is not only part of our company’s culture, it is a core business strategy. We are building a workforce that is representative of our society, and our programs and policies are designed to foster diversity and inclusion.

AODA Declaration
Our goal is to create an environment that is inclusive to all members of the community. Intrinsik Corp., focuses on identifying, removing, and preventing barriers for persons with disabilities, and our policy complies with the Accessibility for Ontarians with Disabilities Act, 2005 (AODA).