Associate Regulatory Affairs Director

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 Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD 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.
• Provide regulatory expertise 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 documents and provide regulatory input (e.g., response documents, high level 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 both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Lead GRST & GRET sub-teams, e.g., Cross functional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
• Develop, implement, 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 communicate 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, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.
• When assigned Lead RPM role ARAD, responsibilities to include:
• Lead the GRET (Global Regulatory Execution Team).
• Overall accountability for the project management of all GRET deliverables.
• Key member of the Global Regulatory Strategy Team (GRST) dedicated to reaching the GRST product plan submission breakthroughs. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members.
• Identify regulatory risks and risk mitigation strategies for GRET executions and deliverables (with input from all team members).
• Drive the GRST and GRET resourcing process.
• Supports Fee forecasting activities.
• Allocate RAM resources to the GRET deliverables.
• Liaise with GPM and other functional project managers.
• Knowledge sharing and RAM development; the go-to person for RAM project guidance and support, provides and facilitates coaching within/between the GRET and GRST.

Essential Skills/Experience

• Relevant University Degree in Science or related discipline
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
• Thorough 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

• Managed first wave Marketing Application and/or LCM submissions
• Managed complex regulatory deliverables across projects/products
• Knowledge of AZ Business and processes
• Background in Oncology Regulatory Affairs

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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.