Stephanie Anderson

Associate Director, Regulatory Affairs

Mississauga, Ontario

Email: moc.k1653709240isnir1653709240tni@n1653709240osred1653709240nas1653709240
Phone: +1 343-961-6164
vCard: Download

Stephanie Anderson is an Associate Director of Regulatory Affairs at Intrinsik Corp.  She has been a regulatory affairs professional within the pharmaceutical/biotechnology industry since 2010. Stephanie has been involved in a broad range of regulatory activities from clinical development to post-registration license maintenance. Her experience includes authoring, review, and submission of CTAs, INDs, NDSs, NDAs, and MAAs to Health Canada, FDA, and the within the EU through Decentralised and Centralised Procedures. She has also provided strategy for and participated in regulatory authority interactions with Health Canada, FDA, EMA (CHMP, COMP, PDCO), BfArM, and MHRA. Stephanie is a member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and the Regulatory Affairs Professionals Society (RAPS). She has contributed to pharmaceutical industry workshops, been an invited speaker on the topic of regulatory affairs, and has authored a chapter for the Fundamentals of Canadian Regulatory Affairs.

Experience Highlights

  • Regulatory affairs strategy development and execution.
  • Preparation of gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
  • Management, preparation, review and filing of regulatory documents and submissions in compliance with applicable regulatory guidelines for the United States, Canada, EU, and MHRA.
  • Oversight of submission quality, timelines and budgets for a range of clients, managing necessary cross-functional resources.
  • Regulatory Authority and client interactions for efficient regulatory submission development.

Education and Professional Qualifications

  • M.Sc., Biochemistry and Physiology, University of Western Ontario
  • Regulatory Affairs Post-Graduate Certificate, Humber College
  • B.Sc. (Honours), Molecular Biology and Biotechnology, University of Waterloo

Professional Affiliations

  • Canadian Association of Professionals in Regulatory Affairs
  • 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