Karen Chiang

Senior Regulatory Affairs Manager

Mississauga, Ontario

Email: moc.k1496128228isnir1496128228tni@g1496128228naihc1496128228k1496128228
Phone: +1 905-364-7800 Ext. 245
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Karen Chiang is a Senior Regulatory Affairs Manager at Intrinsik Corp., who has been a regulatory affair professional in the pharmaceutical industry since 2004.  She has experience in a broad range of development and regulatory activities leading to product registration. Karen has filed multiple applications including CTA, IND, and NDS.  Karen has helped clients navigate Health Canada’s requirements and develop successful filing strategies for Canada.

Experience Highlights

  • Assessed NDAs and MAAs for regulatory, clinical and CMC gaps for filing NDSs in Canada.
  • Efficiently project managed preparation of NDSs and Health Canada review of NDSs by engaging effectively with stakeholders and regulators.
  • Experienced in authoring CMC CTD sections from source documentation.
  • Invited speaker on eCTD submissions to Health Canada.

Education and Professional Qualifications

  • B.Sc., Biology, University of Toronto
  • Certificate in Project Management, University of Toronto
  • Regulatory Affairs Certification, Regulatory Affairs Professional Society
  • RAQC, Pharmaceutical Regulatory Affairs and Quality Operations Certificate, Seneca College

Professional Affiliations

  • Canadian Association of Professionals in Regulatory Affairs
  • Drug Information Association
  • Regulatory Affairs Professionals Society

 

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).

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us