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Regulatory Affairs Associate


CanniMed Therapeutics Inc., a leader in plant-based technologies, is seeking a self-driven individual to join our team as a Regulatory Affairs Associate position. This position will work as a member of the regulatory affairs team and be responsible for the coordination and preparation of regulatory submissions for existing products, research projects, and facilities in a manner which ensures compliance with all appropriate government regulations. The regulatory affairs associate is expected to interpret regulatory requirements, provide input into regulatory strategic planning, and ensure that regulatory requirements are met in support of new and existing products.

Primary Responsibilities

  • Implement effective regulatory processes throughout the different stages of product life cycle and in-line with corporate objectives
  • Creation, revision and maintenance of documents tied to Regulatory Affairs processes management
  • Actively participates in the resolution of technical queries or monitoring reports relating to any submission in a timely manner and within deadlines
  • Work closely with functional groups (Production, Quality, Operations) within the company to ensure all regulatory obligations are met
  • Maintains current awareness of regulatory guidelines and shares knowledge with departments as required
  • Regulatory risk assessment by analyzing, identifying, describing and estimating the risks affecting on-going and future projects

Qualifications

  • Bachelor or Master’s degree is preferred
  • 1-2 years of experience in Regulatory, Quality, or Clinical Research in the medical device/ pharmaceutical/ biologics industry is preferred
  • Strong communication and persuasion skills, the ability to craft strong regulatory arguments
  • Strong problem-solving skills
  • Attention to detail and ability to analyze complex information
  • Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada is an asset
  • Strong analytical skills with the ability to interpret scientific data
  • An energetic team player and results oriented with strong interpersonal and time management skills, able to work to with tight timelines

Salary will be based on skill levels and education. CMED offers a comprehensive benefits package. Incumbents must hold Canadian Citizenship or Landed Immigrant Status.

How to Apply

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