Jon-Paul Powers, Ph.D. Email & Phone Number

Ottawa, Ontario, Canada

Toronto, Canada Area

-Providing clients with scientific advice on matters relating to natural health, cosmetic and food product compliance and enforcement issues and product development strategies-Providing clients with strategic natural health, cosmetic and food product and regulatory guidance and risk assessments -Formulating new natural health, cosmetic and food products with a focus on scientific substantiation and regulatory compliance-Providing scientific reviews focused on risk assessment and hazard analysis of high priority ingredients for natural health, cosmetic and food products-Providing compelling, scientifically supported and regulatory compliant text for natural health and food product advertising materials-Providing complete project management services including outsourcing of all regulatory needs (quality assurance, scientific affairs, etc.)

Toronto, Canada Area

-Served as the senior official responsible for all aspects of regulatory affairs pertaining to the manufacture of natural health products (dietary supplements) and foods -Successfully obtained GMP, Organic and Kosher certifications and maintained a Health Canada Site License-Designed and implemented a new volume of standard operating procedures (SOPs), outlining functionalities of all employees, and focused on establishing and maintaining GMP as per Health Canada NHPD and United States FDA requirements-Designed and implemented a complete, GMP compliant, raw material identification program primarily centered upon the creation and validation of a custom reference standards library-Designed and implemented an efficient finished product skip-lot testing program and coordinated all laboratory testing and data analysis-Served as an industry spokesman through participation in a variety of industry and government working groups and expert panels-Managed a team of quality control professionals and associated budgets

Toronto, Canada Area

-Served as the senior official responsible for all aspects of regulatory affairs and protocols according to Health Canada Food and Drug Regulations, the Natural Health Products Regulations, the Canadian Organic Products Regulations and the United States FDA Dietary Supplements Health and Education Act-Provided strategic natural health product, cosmetic and food regulatory guidance and risk assessments to domestic and international clients -Designed risk mitigation strategies for natural health product, cosmetic and food regulatory non-conformities focusing on minimal disruption to commerce-Formulated new natural health products, cosmetics and foods with a focus on scientific substantiation and regulatory compliance-Conducted scientific reviews focused on risk assessment and hazard analysis of high priority food and natural health product ingredients-Created compelling, scientifically supported and regulatory compliant text for natural health product and food advertising materials-Coordinated the preparation and submission of all natural health product license applications and food temporary market authorization requests-Cultivated close working relationships with senior management of Health Canada and various trade organizations-Worked with legal counsel and regulatory consultants to coordinated the entry and marketing of natural health products and foods in various international jurisdictions-Managed a team of regulatory professionals and associated budgets

Ottawa, Canada Area

-Assessed clinical trial applications with emphasis on risk assessment and risk mitigation-Evaluated scientific data relating to natural health products pursuant to the Food and Drugs Act and Natural Health Products Regulations-Evaluated clinical and pre-clinical scientific data relating to natural health and therapeutic products-Consulted and provided recommendations to stakeholders and senior officials on clinical trial design-Evaluated and assessed adverse reaction reports-Trained and managed assessment officers-Evaluated, maintained and prepared unit performance reports-Developed, authored and implemented standard operating procedures-Represented NHPD on various inter-directorate regulatory and policy working groups

Ph.D., Microbiology & Immunology

Studies focused on the design, development and understanding of cationic antimicrobial peptides and their associated mechanisms of action..

B.Sc., Biochemistry

Undergraduate studies focused predominately on biochemistry and organic chemistry. Honours research project involved the use of one.