Quality Assurance & Regulatory Assistant

Reporting Line: Head of Regulatory Affairs and Director, Quality Assurance

Purpose of Position: 

The incumbent is responsible for providing support to the regulatory and quality departments in coordinating the preparation, maintenance, quality control, organization and storage of the company’s regulatory and quality documentation. The role will also provide specialized administrative support to the group, applying critical thinking and a high degree of judgement and initiative, with knowledge and application of best practices in business administration.

Roles & Responsibilities:

  • Assist the Quality Assurance team with,
    • Maintaining the document system, training records, job descriptions, and CVs
    • Manage the audit findings and notify vendors when due dates are reached
    • Complete data entry for reports and submissions
    • Interact with vendors for document or technical requests
  • Assist the Regulatory Submissions team with,
    • Organize and manage the archiving of all regulatory filings & documentation within the company
    • Assist with regulatory documentation (e.g. formatting, quality control, printing, binding, label creation)
    • Work with internal clinical personnel and external consultants to complete summaries, reports and documents needed for submission to regulatory authorities
    • Follow project plans and timelines for assigned areas of responsibility
  • Arranges internal and external meetings; conference calls; coordinates travel arrangements;
  • Take and prepare meeting notes, minutes and other records;
  • Completes quality checks prior to document release;
  • Process documentation for approvals and signatures;
  • Efficiently and actively organizes assigned calendars and activities;
  • Coordinates various accounting and contracting requirements on behalf of direct Managers;
  • Provide administrative assistance using advanced knowledge of MSOffice and SharePoint;
  • Exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions;
  • Comply with all signatory limits as communicated by the finance function on behalf of the company.
  • Comply with all Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.

Requirements:

  • Highly developed attention to detail (essential).
  • Excellent written and verbal communication skills (essential).
  • Willingness to work in a highly regulated environment (essential)
  • Bachelor’s degree in a health-related/science/business discipline. Professional diploma/certificate would also be considered (asset).
  • Public and/or Pharmaceutical company experience (asset).
  • Intermediate to Advanced Computer skills using MS Word, Excel, PowerPoint, Outlook and SharePoint.
  • 5+ years progressive administrative experience (asset).
  • Ability to work well independently as well as a member of multiple, integrated teams.
  • Proven organizational skills with the ability to establish work priorities and remain flexible in working hours.
  • Positive “can do” attitude and sound interpersonal skills.
  • MUST have the ability to maintain a high level of confidentiality.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc