Jana Berghouwer

Senior Manager, Regulatory Affairs

Mississauga, Ontario

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Phone: +1 905-364-7800 Ext. 231
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Jana Berghouwer is a Senior Manager, Regulatory Affairs at Intrinsik Corp., and has been in the biotechnology and pharmaceutical industry since 2006. She has been involved in a broad range of regulatory activities from the clinical development stage to post-registration maintenance of licenses. Her experience includes authorship, review and submission of CTAs, INDs, MAAs and NDSs for both biologic and small molecule products. She has extensive international regulatory experience, including submissions to Health Canada, FDA and the eastern Europe/Russia region.

Experience Highlights

Customization/authoring and review of documentation for submission to regulatory agencies.
Management of clients, timelines, budgets and milestones for regulatory projects.
Monitoring applicable regulatory requirements for compliance with local and global regulations.
Preparation of gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.

Education and Professional Qualifications

B.Sc. (Honours), Chemistry and Biochemistry, University of Western Ontario
Pharmaceutical Regulatory Affairs and Quality Operations Certification, Seneca College

Professional Affiliations

Canadian Association of Professionals in Regulatory Affairs
Pharmaceutical Sciences Group

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).