Regulatory Affairs Associate – Ontario

Job Summary

An exciting and agile generic pharmaceutical company is excited to announce an opening for a Regulatory Affairs Associate position in the GTA. The Regulatory Affairs Associate will be primarily responsible for the complication and filing of new regulatory submissions for new products with Health Canada in a timely manner

Job Specifications

  • Compile, author and publish regulatory submissions to Health Canada in a timely manner.
  • Prepare product labelling (including Product Monographs) and coordinate French translation.
  • Review submission documentation for compliance with Health Canada requirements. Identify weakness for submission and coordinate with stakeholders to ensure compliance with Canadian requirements.
  • Independently compile and prepare responses to deficiency letter received from regulatory authorities in a timely manner.
  • Liaise with Health Canada representatives, as needed, to support responses to deficiencies and validate submission strategy planning.
  • Communicate with internal and external stakeholders to obtain documents required to support regulatory submissions.
  • Communicate and guide external stakeholders with respect to clinical studies to be performed for the organization.
  • Monitor and maintain regulatory compliance of the product through post-approval activities and filings
  • Remain up to date on applicable regulatory guidelines (Health Canada, FDA, ICH, etc.)
  • Develop departmental working guidelines to document standard processes in the department

Qualifications

  • Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences
  • Must have strong technical knowledge of CMC requirements and is able to critically analyze scientific data
  • Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally)
  • Strong working knowledge of CanadianFood and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines and Health Canada Policies and Guidelines
  • Ability to prioritize workload to ensure all deadlines are met
  • Excellent organization, written and oral communication skills
  • Ability to effectively manage multiple projects in a fast-paced, results oriented environment
  • Strong commitment to quality, accuracy and detail
  • Ability to work well under pressure in a team-based environment

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