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:
Representing the total delivery from Global Regulatory Operations (GRO) capabilities, the Regulatory Dossier Lead demonstrates resilience, manages in ambiguity, and plans GRO delivery comprehensively amidst changing targets, dynamic and fast-evolving environment for large, late-stage development and major lifecycle GRETs.
The Lead Dossier Manager collaborates with teams in the total GRO publishing capability to assure efficient delivery of end-to-end submission output to aggressive project timelines. They create detailed complex cross-functional plans to manage Regulatory, Clinical, and Non-Clinical document and submission publishing deliverables and associated lifecycle and license information. Pursuing innovative ways to compress overall submission timelines, cross-functional alignments, and efficiencies, using relevant planning tools and dashboards.
The Lead is a representative on the Submission Delivery Teams for the GRO total delivery, proactively overseeing the execution of GRO delivery and responding to issues arising. Providing status updates through dashboards for the team. Applying their broad understanding of technical/format aspects, they plan and improve global submission delivery, with expertise in clinical and non-clinical systems.

ACCOUNTABILITIES:

• Lead total publishing (Regulatory, Clinical, and Non-Clinical) and RIM deliverables at Submission Delivery Teams for major late-stage development or major lifecycle Programs
• Measure, maintain, and communicate Key Performance Indicators to indicate progress with efficiencies, quality, integration, outsourcing, and boundary definitions
• Identify and anticipate risks to the GRO deliverables from a complete Regulatory Information product perspective, and propose options to mitigate risks to dossier delivery timelines
• Set clear expectations on GRO deliverables to proactively influence and enable Submission Delivery Team decision making and in-depth planning in a multi-varied delivery environment, including internal and external capabilities (Alliances, Offshoring, and Outsourcing)
• Apply decision-making based on experience and business acumen, using creative thinking for delivery to negotiate/challenge delivery times
• Proactively anticipate market needs, compliance risks with Registration Licenses, and contribute to related Health Authority interactions with technical content
• Lead and provide regulatory expertise on Health Authority submission technical initiatives and requirements, including interpretation of requirements such as Data Sets, CRF Clinical Trial Transparency, Emerging Market formats, and Clinical trials website information
• Ensure and implement adoption of globally agreed Clinical delivery strategies. Identify, plan, and prioritize complex deliverables with Study Team Leaders, Clinical information management directors (for example, CSR, IMPDs, IB, High-level documents)
• Contribute proactively to resourcing submission deliverables through partnerships with GRO or outsourcing partners. Working closely with GRO lead for capacity and assignment
• Provide coaching, mentoring, and training within the GRO skill groups
• Represent GRO and provide leadership on global cross-functional change programs
• Develop and maintain strong partnerships with internal and external key global partners

ESSENTIAL SKILLS/EXPERIENCE:

• University Degree in Science or related discipline
• 5 years or more relevant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
• Leadership skills, including proven leadership of cross-functional project teams experience
• Excellent written and verbal communication skills
• Thorough knowledge of the drug development process
• Thorough scientific knowledge sufficient to understand all aspects of regulatory issues
• Project Management experience or certification
• Knowledge of broader AZ Business and processes
• Appropriate regulatory experience
• Global team experience

Please refer the Job description for details