Heather Bakdache

Regulatory Affairs and Quality Assurance Manager

Mississauga, Ontario

Email: moc.k1511502063isnir1511502063tni@e1511502063hcadk1511502063abh1511502063
Phone: +1 905-364-7800 Ext. 203
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Heather Bakdache is a Manager of Regulatory Affairs and Quality Assurance at Intrinsik Corp.  She has been a regulatory affairs professional within the pharmaceutical/biotechnology industry since 2002.  Heather has worked on a broad range of activities from early clinical development through to post-registration license maintenance.  Her experience includes authoring, review and submission of CTAs, INDs, ANDAs, NDSs and NDAs to Health Canada and FDA.  Heather is a member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and the Regulatory Affairs Professionals Society (RAPS).

Experience Highlights

  • Management, preparation, review and filing of regulatory documents and submissions in compliance with applicable regulatory and guidelines for the United States and Canada.
  • Medical writing and review of Module 2 CTD summaries.
  • Management of projects to oversee quality, science, timelines, and budgets for regulatory submissions.
  • Monitoring of team member training on SOPs, WIs and company policies.

Education and Professional Qualifications

  • M.Sc., Pharmacy (Drug Regulatory Affairs), University of Florida
  • Post-Graduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations, Seneca College
  • B.Sc., Biology, Queen’s University
  • RAC (U.S.), US Regulatory Affairs Certification (accredited 2003)

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