Regulatory Affairs Specialist -International M/F
United Pharma
THIS IS A FULL-TIME IN-PERSON POSITION IN CAMBRIDGE, ON Please send your resume to ***email_hidden***
The successful candidate is responsible for supporting the Regulatory Affairs team in regulatory activities to ensure corporate goals are achieved in a compliant manner. This role will play a vital part in devising, recommending, and implementing regulatory compliant strategies to support business initiatives with a primary focus on our international partners, while working closely with the Research & Product Development and Sales teams to accomplish these goals. The incumbent must have a solid scientific background and knowledge of/experience with the regulation of Dietary Supplements/Natural Health Products.
Support International team by coordinating, generating or requesting various documents to aid in product registrations and importations for regions including Latin America, Middle East and Europe.
Support International and Canadian team on new product research and development by the evaluation of formulations and labels for compliance
Demonstrate an ability to monitor, inform, suggest, recommend and apply, after necessary approval from manager, actions necessary to meet and maintain regulatory (food and drug) compliance
Coordinate Canadian submissions and site license renewal with Natural and Non-Prescription Health Products Directorate
Postgraduate Certificate in Pharmaceutical Regulatory Affairs and Quality Assurance is an asset
Minimum 1-2 years of regulatory affairs experience preferably within a consumer packaged goods regulated environment (direct dealings with FDA, NNHPD)
Proficient in the use of MS Office Suite
Solid knowledge of research tools i.e.
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