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Regulatory and Scientific Affairs Associate - Natural Health Products

Location:	Windsor, Ontario, Canada
Job Type:	Permanent
Posted:	31st Mar 2011
Closing Date:	28th Apr 2011
Posted By:	SECONDLIFE Global
Details:
Regulatory and Scientific Affairs Associate - Natural Health Products Regulatory and Scientific Affairs Associate, permanent full time opportunity with a natural health products company. This position is responsible for participating in all activities relating to local and international regulatory compliance including preparation and review of regulatory submissions. In addition, this position will include support of various scientific activities of the company including review of recent relevant scientific literature, preparation and update of product monographs, and responses or comments on to recent media postings. This position ensures the appropriate licensing and scientific description’ s of the company's products. Key Duties and Responsibilities * Put together completed product dossiers for various international markets as indicated from the export department; including any QA/QC papers, labels and product samples. * Work with our agents/distributors in export markets in obtaining and clarifying information with regards to the required product dossiers. * Co ordinate the label process including translation * Address and Coordinate the resolution of customer regulatory issues. * Compiles all materials required for submission, license renewal and annual registrations. * Conduct literature research in support of new product license applications. * Review data critically, identify registration issues; develop solid scientific knowledge based strategies to ensure timely approvals. * Compile and prepare responses to deficiency letters received from regulatory agencies. * Review labels, raw material test specifications and finished product test specifications to ensure they meet the requirements of the regulatory agency. * Effectively prioritize, track and complete multiple projects within established timeframes. * Manage and ensure maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies. * Keeps abreast of regulatory procedures and guidelines (domestic and international) and communicate to management. * Work with Marketing, Formulation Development and Supply regarding the introduction of new products to the market. * Review Change Controls regarding changes to existing processes and specifications for their impact to product license status. * Answer relevant technical questions concerning company products. * Review current scientific evidence to make recommendations for new product development or product revisions * Write technical and consumer friendly monographs and descriptions of the company’ s products * Write regular columns on important or pressing issues (scientific and regulatory) in the peer-reviewed literature or popular press. * Assist sales representatives with technical questions. * Performs other duties as required or assigned by the Chief Scientific Officer and other senior officials SKILLS/QUALIFICATIONS REQUIRED: Minimum of 2 years of related experience in a similar capacity in scientific and regulatory affairs in a natural health products company or related industry and knowledge of natural health product directorate and international experience strongly preferred. B.Sc. in Science or equivalent education and experience. Strong Computer literacy, specifically with word processing and database software.

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