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December 28, 2009
Job Opportunity - Director of Regulatory Affairs

*** Posting now closed, thank you. ***

Source Nutraceutical, Inc. is a fast-growing “One-Stop-Shop” for Canadian compliance, regulatory, GMP licensed warehousing and graphic design service company. With offices in Winnipeg, Manitoba and Vancouver, British Columbia the company serves the natural health product, food, functional food, OTC drug, medical device and cosmetic industries by providing integrated regulatory, packaging compliance, graphical, marketing support and order fulfillment services. We have a substantial and growing domestic and foreign client base.

The company has a newly created position of Director of Regulatory Affairs in the Winnipeg corporate office. The right candidate will provide the leadership, management, and vision necessary to ensure that the regulatory department delivers its services with the appropriate operational controls, administrative and reporting procedures, and people systems in place to grow the organization.

Duties and Responsibilities

  • Responsible for the overall direction, coordination, and evaluation of regulatory operations. Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
  • Responsible for motivating, training and managing regulatory project teams.
  • Ensure that the Regulatory Affairs are performed in compliance with the regulations established by Health Canada and within the quality assurance standards of the Company and to the satisfaction of the clients.
  • Maintain and apply an expert knowledge of the Drug / Natural Health Product / Medical Device industry regulatory affairs disciplines, including development, promotion, advertising, labeling, commercialization and operations.
  • Interpret Health Canada regulatory authority policies and guidance and correctly apply them as appropriate in client product development and labeling regulatory activities.
  • Direct and manage department’s projects and deadlines required for meeting market authorization for products.
  • As necessary direct the review of detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • Assess project risks, and where appropriate, recommend contingency plans, and strategies to mitigate regulatory risks.
  • Establish and maintain necessary vendor and trade relationships.

Education and/or Experience:

Required:  Graduate Degree in Biological Sciences, biochemistry related experience or Food and/or Nutritional Science
Preferred:  Ph.D. in Food and/or Nutritional Science
                :  Business Administration Degree

A minimum of 7-10 years experience in a food or nutritional research laboratory including 5 years in a senior management role.

Those with the required education and management experience are invited to apply with résumé
via email to: info@sourcenutra.ca

*Only qualified candidates will be contacted - Applications close January 24, 2009
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