Heather Bakdache

Director, Regulatory Affairs and Quality Assurance Manager

Mississauga, Ontario

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Phone: +1 905-364-7800 Ext. 203
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Heather Bakdache is a Director 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