Regulatory Affairs Manager
Regulatory Affairs Manager
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Salary Not Disclosed
1 Vacancy
Job Description
At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious 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 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 were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.
Introduction to role:
Are you ready to lead the charge in regulatory affairs As a Regulatory Affairs Manager (RAM) youll be leading the planning coordinating and completing of regulatory deliverables. Your expertise will shape submission strategies identify risks and opportunities and guide complex applications through approval. Collaborate with cross-functional teams providing regulatory insights and ensuring business objectives are met across regions. Are you prepared to make a difference
Accountabilities:
- 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.
- Implement standard methodologies for 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 products life cycle from either a global and/or regional perspective.
- Develop implement and maintain submission delivery plans submission content plans and provide status updates to designated collaborators proactively.
- 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 crafting work requests and submission content plans tracking submissions managing TMF and documents using 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.
Essential Skills/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
- Excellent written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g. MS Project) and document management tools
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused
Desirable Skills/Experience:
- Regulatory experience
- Managed regulatory deliverables at the project level
- Thorough knowledge of the drug development process
- Knowledge of AZ Business and processes
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 11 years
- Top 100 Employers Award
- Canadas Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel
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.
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Date Posted
16-Jul-2025Closing Date
17-Aug-2025AstraZeneca 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.
Required Experience:
Manager
Employment Type
Full-Time
