Regulatory Affairs Manager (RAM)
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 we’re 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
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
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Assigned deliverable(s):
- 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.
- Apply and share standard methodologies for handling various applications and procedures 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, complete, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
- 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 assistance and input of GRO, MCs, CROs, and/or alliance partners where applicable.
- 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 collaborator 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 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
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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 AZCHumanResources@astrazeneca.com.
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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.
