Regulatory Affairs Manager (9-month contract)
This is a 9-month contract
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.
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 guidelines, 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, 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 generating work requests and submission content plans, submission tracking, TMF, and document management applying 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.
Use available AI tools effectively and responsibly to improve efficiency, streamline routine activities and support high quality regulatory deliverables.
Minimum Requirements –Education and Experience
Relevant University Degree in Science or related discipline
2-4 years of experience in 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
Preferred Experience
Regulatory experience
Managed regulatory deliverables at the project level
Thorough knowledge of the drug development process
Knowledge of AZ Business and processes
Skills and Capabilities
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
Internal and External Contacts/Customers
Global Regulatory Leads (GRLs)
Regional Leads (eg, US, EU international RADs)
Lead RPM
Regulatory skill groups in ORSS, Late R&I and Late CVRM
Other R&D functions
Marketing Companies
Health Authorities
External collaboration partners
Reporting Relationship
Direct Reports - None
Indirect Reports -None
Great People want to Work with us! Find out why:
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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Annual base salary for this position ranges from 107,196.80 to 140,695.80.AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
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