Regulatory Affairs Operations Excellence Associate (12 Month Contract)

AstraZeneca

Toronto, Canada
Base: 75,752.00 - 99,424.50; bonus/equity: variabl...
Health canada correspondence processing
Global regulatory information management system
Product monograph processing
You will work collaboratively with Local and Global Regulatory teams, as well as cross-functional teams, to provide comprehensive operational capabilities and support in the core RAOE functional areas of Regulatory Submission Enabling, Labelling, Compliance and Intelligence

Job Summary

  • You will work collaboratively with Local and Global Regulatory teams, as well as cross-functional teams, to provide comprehensive operational capabilities and support in the core RAOE functional areas of Regulatory Submission Enabling, Labelling, Compliance and Intelligence.
  • Your role will be crucial in supporting the timely and high-quality preparation and delivery of Canadian submissions and optimization of product labelling in accordance with AstraZeneca standards and our local GxP Quality Management System (QMS).
  • AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues, with a base salary range of 75,752.00 to 99,424.50 for this position.

Matching Summary

You will work collaboratively with Local and Global Regulatory teams, as well as cross-functional teams, to provide comprehensive operational capabilities and support in the core RAOE functional areas of Regulatory Submission Enabling, Labelling, Compliance and Intelligence.

Salary

Base: 75,752.00 - 99,424.50; Bonus/Equity: Variable Pay Bonus/Short Term Incentive opportunity and equity-based long-term incentive program (if applicable); Benefits: Contract Benefits Program

Skills & Requirements

Must-have

  • Health Canada correspondence processing
  • Global Regulatory Information Management System
  • Product Monograph processing
  • Quality Management System activities
  • Health Canada regulatory environment

Nice-to-have

  • Collaborative team player
  • Customer-focused approach
  • Technological agility
  • Ambitious thinking and innovation
  • Sustainability dedication

Key Requirements

  • University degree in health science or equivalent
  • 1-2 years related experience
  • Knowledge of Canadian regulatory environment
  • Familiarity with electronic labeling systems
  • Proficient in MS Office and document management systems

Work Rights

Not specified

Tailored Resume

Cover Letter