Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to build a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely crafted with teamwork in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our environment and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Responsibilities:

• Assist in the development and implementation of CMC and Establishment License (EL) submission strategies which will facilitate the submission review process with a strive to deliver Health Canada approvals in support of business objectives.
• Review chemistry and manufacturing documentation for compliance vs AZ standards and Health Canada regulations. Convey recommendations to management.
• Prepare and submit regulatory files (NDSs, SNDSs, NCs, Level Changes) in adherence with the Food and Drugs Regulations and Medical Device Regulations, as appropriate, for submission to the Pharmaceutical Drugs Directorate (PDD), Biologics and Radiopharmaceutical Drugs Directorate (BRDD), and Health Products and Food Branch Inspectorate (HPFBI), Health Canada.
• Facilitate submission approvals through effective negotiation and communication with PDD, BRDD, and HPFBI.
• Maintain registration compliance for assigned projects to support ongoing manufacture and/or marketing of products in Canada.
• Develop, foster and maintain positive relationships with all stakeholders involved in the lifecycle management of our brands.
• Help monitor changes to Regulatory environment (regulations, guidelines, policies, etc.) as directed by Manager.

Essential:

• B.Sc. or equivalent in a related (chemistry, health science) field. Advanced degree (M.Sc.) considered an asset as well as experience with Biologics and Establishment Licenses.
• Previous experience in Regulatory Affairs mandatory.
• Current knowledge of cGMP, CMC Regulatory and ICH guidelines.
• Able to balance and progress multiple projects across all therapeutic areas.
• Proficient in the use of Microsoft Office and Veeva Platforms (e.g. Enterprise Regulatory Vault ERV).
• Problem-solving ability and innovative thinking.
• Attention to detail, balanced with understanding of business objectives.
• Commitment to teamwork.
• Customer-focused.

Desirable:

• Therapeutic area, product and brand knowledge
• Knowledge of local and international regulatory activities and trends

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

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 07-Sept-2023

Closing Date 20-Sept-2023

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 authorization and employment eligibility verification requirements.

AstraZeneca