Regulatory Affairs Manager
4 months ago
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.
**Our position**:
**Accountabilities/Responsibilities**:
- Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
- 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.
- 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.
- 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 field
- At least 1 year of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other proven 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:
- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel
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