Senior Director, Regulatory Affairs
Phone: +1 905-364-7800 x 209
Katharine Manson is a Senior Director of Regulatory Affairs at Intrinsik Corp., Katharine holds a post-graduate certificate in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College and a Canadian Regulatory Affairs Certification and has been a consultant to the biotechnology industry in pharmaceutical and healthcare since 2003.
Katharine works with a wide variety of clients to assist with product development goals. She does this by creating strategic product development plans aimed to meet scientific, regulatory and business needs, planning and coordinating submissions, and identifying and pre-empting regulatory issues. Her focus is on North American regulatory affairs, with particular knowledge of the regulatory aspects of U.S. pharmaceutical product development, and she has extensive experience with multiple pharmaceutical applications including NDS, CTA, NDA, and IND. Her proficiency encompasses both small molecule and biologic compound applications.
Katharine serves with the Canadian Association of Professionals in Regulatory Affairs (CAPRA) as the Toronto Dinner Meeting Chair. She is also a member of the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), and the Pharmaceutical Sciences Group (PSG). She has contributed to various pharmaceutical industry workshops, co-authored a paper for the Canadian association of Professional Regulatory Affairs, and has been a contributing editor for RAPS Fundamentals of Canadian Regulatory Affairs.
- Oversees the implementation of regulatory affairs strategies.
- Communicates with Regulatory Agencies and clients to facilitate regulatory submissions.
- Provides regulatory guidance on clinical operations activities.
- Prepares and files regulatory documents and submissions in compliance with applicable regulations and guidelines (pre-IND, IND, pre-CTA, NDA, NDS, MAA) in electronic eCTD, NeeS, and paper formats.
- Interacts with clients and internal scientists to develop timelines for filings.
- Provides regulatory guidance on CMC and pharmaceutical development issues.
- Manages and mentors regulatory staff.
- Published author in the field of global regulation related to the nonclinical development of new drugs and biopharmaceuticals.
Education and Professional Qualifications
- B.Sc. (Honours), Biomedical Sciences, University of Guelph
- Pharmaceutical Regulatory Affairs and Quality Operations Certification, Seneca College
- Canadian Association of Professionals in Regulatory Affairs
- Drug Information Association
- Pharmaceutical Sciences Group
- Regulatory Affairs Professionals Society