Director, Regulatory Science and Policy

We take innovative regulatory approaches and are building out a best-in-class Regulatory Science team to support R&D as well as digital solutions including digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions.  

Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a health-tech business within the AstraZeneca Group. 

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

We’re building out a best-in-class Regulatory Science team to support R&D as well as digital solutions including digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions. 

Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of great promise, with the World Health Organisation believing it has the potential to improve health for everyone. At AstraZeneca, we’ve been working hard to make this a reality, with the years of experience we have accumulated enabling us to now embed digital health at scale across R&D. To achieve our goal of improving patient experience and outcomes AstraZeneca has Digital Health as one of the top 4 strategic priorities for the company, details on digital health strategy can be found here. Oncology is the largest therapeutic area within AstraZeneca and second highest cause of death globally, with AstraZeneca’s ambition to eliminate cancer as a cause of death.

Director, Regulatory Science and Policy will provide strategic and operational regulatory leadership to influence the development, commercialization and life cycle management of innovative assigned product(s) across all stages of development. The successful candidate will be responsible for defining and implementing regulatory strategies for digital health technologies, clinical outcome assessments (COAs), and novel endpoints in drug development, and engage with health authorities to effectively inform our development programs. The Director will be expected to build a regulatory framework that accelerates generation and use of data/multi-modal evidence for medical product development which will involve working closely with cross-functional teams to ensure that regulatory requirements are met throughout the development process. As regulatory policy is essential to enable innovation, the Director will be responsible to identify and prioritize business needs to inform policy solutions, monitor the policy environment to communicate trends internally and assess implications to business and build relationships and communicate priorities to key stakeholders. The Director should be published as an expert within this area of specialization.

What you’ll do

As the Director, you will play a pivotal role in leading our scientific capabilities to make a positive impact on changing patients’ lives through the following:

• Develop and implement regulatory plans, strategies and approaches for integrating digital health technologies into research.
• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Deliver regulatory milestones including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of regulatory strategy documents.
• Collaborate and communicate closely with cross-functional teams to ensure that regulatory requirements are met throughout the drug development process.
• Own the relevant regulatory activities and provide strategic input on key development and regulatory documents. Ensure global regulatory plans supporting digital approaches, including regulatory submission plans, health authorities (HA) engagement plans and mitigation strategies.
• Remain current with relevant regulatory guidelines and developments in the field of digital health technologies and drug development.
• Ensure high quality collaboration with global regulatory leads and provides guidance to the regional strategists in strategic meetings with health authorities.