Job Description

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial thinking and innovation - 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 create 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 designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our commitment to sustainability is also central to our culture 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're taking bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Are you strategic and solution-oriented? Do you enjoy detailed work and challenging the status quo? Are you passionate about improving processes and project management?

As the Regulatory Affairs Project Manager, you provide regulatory input and direction to the Canadian Cross Functional Team and Global regulatory teams to build regulatory strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact a product's potential and lifecycle in the Canadian marketplace. You actively support the team to maximize efficiency, performance and productivity. You ensure your responsibilities are delivered in compliance with AZ Corporate responsibility policies.

Your responsibilities will be:

Build and implement regulatory strategic plans including Regulatory Strategy Documents

Prepare, submit and negotiate of approvals of NDSs and SNDSs

Maintain regulatory compliance of approved products

Plan and conduct Health Canada meetings to ensure positive outcomes; work with external experts and participate in key external advisory boards

Build and release Health Professional and Public Communications

Review and approve promotional materials including artwork

Compile responses to ATI requests

Provide strategic and informed regulatory/business expertise across the organization as required

Influence the global development of products, representing the Canadian market, to mitigate regulatory risks in the development plans

Lead or participate in cross-functional and external initiatives

Ensure regulatory submissions and documents are aligned with both HPFB and AZ requirements and standards (e.g., Electronic submission processes)

Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys

Provide expertise and support to junior staff members (associates, students and assistants) to positively encourage development and knowledge transfer

Your qualifications include:

B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) is an asset

Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines

Knowledge in one or more of the following key therapeutic areas CV-Metabolism, Oncology, and Respiratory/Immunology is ideal

Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries

Minimum 2 years regulatory project management experience

Proficient in the use of MS Office

Your strengths include:

Superior negotiation skills, problem solving ability and innovative creative thinking

Excellent time management and organizational skills (able to manage multiple projects and priorities effectively)

Keen detail orientation to identify errors

Strong written and verbal presentation skills and adept at crafting business proposals and project plans

Ability to identify risk and build a plan to mitigate the risk

Positive interpersonal and relationship building skills with the ability to work effectively in a team both internally and externally

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

GTAA Top Employer Award for 8 years:

Best Workplace Culture Award at the 2018 Canadian HR Awards:

Learn more about our culture:

Browse AstraZeneca's Oncology YouTube channel to find out more about our focus:

Are you interested in working at AZ, apply today!

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca's determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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 14-Oct-2022

Closing Date 23-Oct-2022

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.