Hybrid Regulatory Affairs Intern – Pharmaceutical Lifecycle Support

Posted last week

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About the role

  • Support for regulatory submission activities related to clinical operations: converting product monographs into a new format; assisting in the preparation of documents for clinical activities; preparing a response template (question-and-answer document) to address Health Canada requests.
  • Support for chemistry, manufacturing and controls (CMC) activities and projects: tasks related to certified product information documents (DCIP); tasks related to applications for pharmaceutical establishment licences (LEPP); assisting in the preparation of documents for CMC activities; preparing a response template (question-and-answer document) to address Health Canada requests.
  • Support for labeling and proofing activities: reviewing artwork and proofs required for regulatory filings; maintaining tracking tools, databases, and product registers; supporting Special Access Program activities by preparing supporting documentation for Special Access Program drug requests.
  • Regulatory correspondence and archiving of regulatory documents: archiving correspondence and documents in an electronic repository.
  • Support for tracking/databases for environmental assessment needs: documentation related to environmental assessment reports.

Requirements

  • Must hold a university degree in health sciences or equivalent
  • Must excel in communication and time management and be able to work independently with minimal supervision
  • Ability to work collaboratively with others (internal and external)
  • Strong communication skills to convey and receive information in English and French
  • Good organizational skills and ability to prioritize tasks
  • Attention to detail and commitment to quality of work

Benefits

  • Flexible work arrangements

Job title

Regulatory Affairs Intern – Pharmaceutical Lifecycle Support

Job type

Experience level

Entry level

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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