Katharine Manson

Vice President, Regulatory Affairs

Mississauga, Ontario

Email: Phone: +1 905-364-7800 x 209 vCard: Download

Katharine Manson, a distinguished professional in the field of Regulatory Affairs, serves as Vice President at Intrinsik Corp. With a strong educational foundation, Katharine holds a post-graduate certificate in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College and is a certified Canadian Regulatory Affairs professional. Her extensive career in pharmaceutical and healthcare consulting, which began in 2003, has made her a recognized authority in the industry.

Katharine’s expertise lies in guiding clients across the biotechnology and pharmaceutical sectors toward their product development objectives. She possesses the unique experience of working in both the US and Canada, bringing a global perspective to her work. She has successfully navigated a wide spectrum of therapeutic areas, encompassing both small molecule and biologic compounds. Her approach encompasses the formulation of strategic development plans that harmonize scientific, regulatory, and business considerations. She excels in orchestrating regulatory submissions, adeptly identifying and preempting regulatory challenges, and ensuring that projects align with North American regulatory standards. Notably, she possesses deep knowledge of the U.S. pharmaceutical product development landscape and boasts a wealth of experience with various pharmaceutical applications, including NDA, IND, NDS, and CTA submissions.

Beyond her professional roles, Katharine actively contributes to the regulatory community. She proudly serves as the Toronto Dinner Meeting Chair at the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and maintains memberships in esteemed organizations such as the Regulatory Affairs Professionals Society (RAPS), the Drug Information Association (DIA), and the Pharmaceutical Sciences Group (PSG). Her dedication extends to participating in pharmaceutical industry workshops and educational presentations for professional associations.

Experience Highlights

• Expertly crafts and oversees the implementation of regulatory affairs strategies.
• Facilitates communication with Regulatory Agencies and clients to streamline regulatory submissions.
• Provides valuable regulatory insights into clinical operations activities.
• Prepares and files regulatory documents and submissions, meticulously adhering to applicable regulations and guidelines, spanning pre-IND, IND, pre-CTA, NDA, NDS, and MAA, across various formats.
• Collaborates closely with clients and internal scientists to develop well-defined timelines for regulatory filings.
• Offers guidance on CMC and pharmaceutical development matters.
• Distinguished mentor, overseeing and nurturing regulatory staff.

Education and Professional Qualifications

• B.Sc. (Honours) in Biomedical Sciences, University of Guelph
• Post-graduate Certification in Pharmaceutical Regulatory Affairs and Quality Operations, Seneca College

Professional Affiliations

• Canadian Association of Professionals in Regulatory Affairs (CAPRA)
• Regulatory Affairs Professionals Society (RAPS)
• Drug Information Association (DIA)