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Regulatory Affairs Manager

Location Mississauga, Ontario, Canada Job ID R-141213 Date posted 16/06/2022

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.

To best support our employees in balancing personal and work commitments,we’ve embraced a hybrid model of workingthat gives employees flexibility in how they manage their time. 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.

Our position:

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

  • Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

    • Submission delivery strategy of all dossiers and all application types per market and /or region.

    • Review of documents (e.g. response documents, study protocols, PSRs, etc.).

    • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

  • Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.

  • Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.

  • Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

  • Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.

  • Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.

  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.

  • Provide coaching, mentoring and knowledge sharing within the RAM skill group.

  • Contribute to process improvement.

Minimum Requirements –Education and Experience

  • Relevant University Degree in Science or related discipline

  • Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

  • General knowledge of drug development

  • Strong project management skills

  • Leadership skills, including experience leading multi-disciplinary project teams

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’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 emailingAZCHumanResources@astrazeneca.com.



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.

50056703 D RGPD R&D Oncology (Susan Galbraith (07016555)) (85008610)

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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.