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 a Regulatory Dossier Lead you provide a Global Regulatory Operation (GRO) interface to Regulatory partners and your responsibility is to plan and agree delivery plans for Major Submissions (NDA, MAA, BLA), coordinate resources, navigate in the operational environment and manage the submission projects to regional partners and Health Authorities.

Your responsibilities could include, but are not limited to:

Collaborate with project teams to assure efficient delivery of submission output and ensuring compliance for submission deliverables

Define and agree cross functional delivery plans and lead times

Coordinate cross function deliverables and GRO publishing resources

Proactively oversees the execution of GRO delivery and respond to issues arising

Providing status updates through dashboards for the team

Apply deep understanding of technical aspects of submission delivery worldwide to assure strategic planning and efficiencies

Develop and maintain strong partnerships with internal and external customers and partners

Minimum Qualifications:

BA/BS in Regulatory Affairs or other scientific/technical field

Minimum of 3 years\xe2\x80\x99 experience in pharmaceutical/medical industry

Strong analytical and critical thinking ability

Comprehensive knowledge of pharmaceutical drug development process

Proven leadership skills of global cross functional project teams

Relevant experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry

Experience of working with Regulatory document or submission publishing, understanding the different formats and market requirements

Preferred Qualifications:

Experience of planning for and managing submission publishing activities

Experience of Regulatory Life Cycle Management

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

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\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 24-Apr-2023

Closing Date 01-May-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