Regulatory Affairs Associate

Scarborough, ON, Canada

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 Schedule:
  • Day shift
  • Monday to Friday
Work Location: One location

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Job Detail

  • Job Id
    JD2107417
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Scarborough, ON, Canada
  • Education
    Not mentioned