Regulatory Affairs Associate
Job Description
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.
Additional Responsibilities:
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.
Ability to file NPN application .
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
Review and update internal Standard Operating Procedures, as needed
Other role related duties as assigned
Core Competencies:
BSc in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent, preferred 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) Knowledge of Canadian Natural and Non-Prescription Health Products Regulations, including Product License Applications Experience applying NPN with Health Canada Key skills include: Results-driven, accountable/own tasks, detail oriented, effective communicator and able to problem-solve with multiple priorities at one time Proactive and able to manage change in an extremely fast paced, energetic work environment Proficient in the use of MS Office Suite Solid knowledge of research tools i.e. PubMed
Job Types: Full-time, Part-time, Fixed term contract
Pay: From $20.00 per hour
Work Location: In person
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Job Detail
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Job IdJD2969291
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCambridge, ON, CA, Canada
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EducationNot mentioned