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 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 dedication 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\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.

As Regulatory Information Manager you will be an authority in end-to-end tracking and documentation, which includes set-up, follow up and documentation of regulatory submissions and approval information. As a Regulatory Information Manager you will also be a guide in understanding Health Authority legislation interpretation as well as the regulatory requirements with regard to licenses and clinical trials aspects of tracking and life-cycle management.

To be successful in this role you have to show a demonstrated ability to work collaboratively in a distributed team environment and have good project management skills. You need the ability to work independently and to set and lead priorities, resources, performance targets and project initiatives in a global environment. It is important that you can demonstrate an understanding of the characteristics in building successful supplier relationships, supervises Service Level Agreements (SLAs) and runs routine quality, resource and performance issues to resolution.

Essential Requirements

• Minimum 1 year hands-on experience with tracking of regulatory information.
• University degree or equivalent experience in life sciences or technical field.
• Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals.
• Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and mentorship and clearly communicate requirements to immediate partners.
• Ability to use project management principles and techniques.
• Experience from planning of large and sophisticated business activities.
• Demonstrates a broad solid understanding of process improvement methodologies, tools, techniques and their application.
• Excellent English written and verbal communication skills.

Desirable Requirements

• Experience of system administration for validated applications within a regulated environment.
• Knowledge of AstraZeneca submission, publishing, approval processes, tools and standards.
• Experience in using Regulatory Information tracking tools.
• Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and make valuable contributions to the business.
• Good problem and conflict resolution skills.

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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\xe2\x80\x99s 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 18-Jul-2023

Closing Date 31-Jul-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