Regulatory Affairs Specialist

6 days ago

Laval, Quebec, Canada Team Aaa Full time

**Job Summary**

We are Team Aaa, a global diversified pharmaceutical company dedicated to delivering better health outcomes. Our team is passionate about enriching lives through our relentless drive to provide essential care to millions of people globally.

**Key Responsibilities**

  • Ensure the coordination of compliance activities, including supplier management, licensing quality agreements, internal audit, and investigations.
  • Coordinate activities internally related to compliance systems and ensure key performance indicators (KPIs) are tracked and communicated.
  • Manage quality agreement updates within required timelines.
  • Coordinate new quality agreements issuance.
  • Provide quality support for investigations and participate in SWOT team activities for site investigations.
  • Manage the investigations system, ensuring investigations are completed on time and as per requirements.
  • Responsible for filing of DELs, Table A, and other site licenses.

**Requirements**

  • Bachelor's degree in science or equivalent combination of experience and academic education.
  • Proficiency in French and English.
  • Experience in GMP, quality systems, investigation writing, and audit.
  • Knowledge of investigation writing tools (5 whys/ Ishikawa).
  • Proficiency in Microsoft Office tools.

**Company Culture**

We are committed to building diverse teams, representative of the patients and communities we serve. Our inclusive workplace cultivates collaboration and fosters a culture of respect and empathy.

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