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Project Manager, Regulatory Affairs - CMC

Location Mississauga, Ontario, Canada Job ID R-083197 Date posted 06/17/2020

Contract 18 months, full-time

Mississauga, Head Office

Working as a valued member of our Regulatory Affairs team, the Regulatory Affairs Project Manager will build positive relationships across AstraZeneca and with external contacts to ensure access to AstraZeneca medicines for Canadian patients.

Responsibilities:

  • Leads CMC Regulatory product submission strategy, proactive risk management and tactics for New Drug Submissions (NDS), Clinical Trial Applications, Post-Approval Variations and Environmental Assessments
  • Coordinates assembly of submission-ready components to support NDS and high-priority post-approval variations
  • Reviews and approves CMC post-approval variations
  • Leads the planning and conduct of CMC-related meetings, interactions and consultations with Health Canada and applies relationship management principles in line with Regulatory Affairs Health Canada plan
  • Leads Establishment License (EL) submission strategies and facilitates the submission review process with an aim to deliver DEL approvals in support of business objectives
  • Prepares regulatory files in adherence with the DEL Regulations, as appropriate, for submission to Health Canada (HC)
  • Leads Establishment License-related interactions, meetings and discussions and facilitates submission approvals through effective communication with HC
  • Maintains DEL registration compliance for all marketed products to support ongoing/timely importation and distribution in Canada
  • Works in partnership with local and global contacts across AZ, including Global Regulatory Affairs, Pharmaceutical Development, and Operations
  • Provides Regulatory Intelligence to support the operational and tactical regulatory CMC and Establishment License contribution and direction to AstraZeneca product and project teams i throughout the product the life cycle
  • Builds networks and processes to ensure that learning from own projects are shared with other colleagues within the department and other relevant project/product teams
  • Provide feedback on draft HC guidelines/legislation/policy, particularly if the document relates to CMC.
  • Ensures compliance with departmental and company standard operation procedures and processes
  • Contributes to the development of new guidance, policy, and processes
  • Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures.

Required Qualifications:

  • B.Sc. or equivalent in a related (chemistry, health science) field; advanced degree (M.Sc. or Ph.D.) considered an asset
  • Minimum of 3 years regulatory experience in the brand name pharmaceutical or biotechnology industries; CMC-related experience is preferred
  • Excellent project management, time management, attention to detail and organizational skills
  • Excellent written and verbal communication skills, is able to influence and resolve issues
  • Strong Interpersonal skills and builds positive relationship when working with a team
  • Problem solving ability and innovative to find new ways of working
  • Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines
  • Current knowledge of DEL regulations, cGMP, CMC Regulatory and ICH guidelines.

About AstraZeneca:

Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act quickly. We are daring, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and new ways to work. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career? Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to achieve our goal.

Great People want to Work with us! Find out why:

Apply today!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.