- Performing key pre approval and post approval activities for drugs intended for the Canadian marketplace.
- Preparation of DIN applications for submission to Health Canada.
- Product license and site license applications and amendments for natural health care products.
- Drug establishment licenses for Canadian importers, packagers and distributors.
- Responses to Health Canada deficiency notices.
- Related to Notice of Compliance (NOC) issues.
Independent Consultant, President, 2003 - Present
Canadian pharmaceutical regulatory affairs and services.
- Compiling product license applications and site license applications for natural health products.
- Compiling new drug submissions, supplemental new drug submissions and DIN applications.
- Clinical trial applications and notifiable changes for Health Canada.
- Managing Access to Information (ATI) requests by third parties.
- Coordinating appeals of Health Canada decisions, providing complete responses to Health Canada deficiency notices within given deadline.
Ferring Inc., Manager, Regulatory and Technical Affairs, 1994 - 2002
- Pre approval activities for pharmaceuticals.
- Coordinated and moderated any necessary NDS and IND-related Health Canada meetings, including relevant follow-up activities.
- Compiled complete NDSs and S/NDSs for products in therapeutic areas of urology, gastroenterology, infertility, obstetrics and gynecology which allowed for successful marketing of numerous pharmaceuticals/biologics of various dosage forms.
- Provided complete responses to all deficiency notices (clarifaxes, notices of deficiency/non-compliance) within given deadlines resulting in continuation of scientific review of all files.
- Organized all activities related to appeals of Health Canada's decision to withdraw files, including securing and moderating Level 1 and Level 2 appeal meetings.
Post Approval Activities
- Handled all Access to Information (ATI) requests by purging all information classified as trade secret information to prevent third parties from obtaining this information through ATI requests.
- Submitted and received approval for all notifiable changes for marketed products (such as change in formulation, change in manufacturing location) during the life-span of products.
- Submitted and received approval for all clinical S/NDSs, including changes to dosing, and addition of alternative indications/routes of administration.
- Compiled and received approvals for CTAs for marketed products seeking additional indications.
- Provided complete submissions to all provincial governments and secured listings on their formularies, for several products.
- Successfully registered updates to provincial governments regarding product changes, such as formulation changes or change in manufacturer.
Procter and Gamble, Manager, Regulatory Affairs, 1992 - 1994
- Reporting to Team Leader for Oral/Gl Care.
- Submitted and received approval for DIN submissions for OTC products.
- Submitted and received approval for changes to marketed products; such as label claims and revised dosing.
Novopharm Ltd., (TEVA), Regulatory Affairs Associate, 1990 - 1992
- Preparation of complete generic NDSs for parenteral pharmaceuticals in therapeutic area of antibiotics and antineoplastics and related product master files on behalf of foreign raw material suppliers.
- Provision of complete responses to notices of deficiencies from Health Canada for all parenteral new drug submissions.
Honors & Publications
Academic and Professional Affiliations
- Canadian Association of Professional Regulatory Affairs (CAPRA)
- Regulatory Affairs Professional Society (RAPS)
- M. Sc. Nutritional Sciences, Faculty of Medicine, University of Toronto, Canada
- B. Sc. Nutritional Sciences, University of Toronto, Canada