CMC Regulatory Affairs Associate Director - Devices and Digital Therapeutics
Location: Cheshire East
Job Type: Full time
We are looking for someone with expertise in medical device and combination product regulatory affairs and passion for digital therapeutics. Would you like to apply your expertise to impact the development and approval of life changing medicines and medical devices? Then AstraZeneca might be the one for you!
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.
Chemistry, Manufacturing, and Controls (CMC)
CMC Regulatory Affairs provides expertise in CMC Regulatory strategy, operational, tactical, and decision-making for sophisticated products from development phase through to global launch and post approval lifecycle management. We are located within the Oncology Regulatory Science Strategy & Excellence (ORSSE) team which sits within the Oncology R&D business unit. We drive innovative regulatory strategies that transform science into life-saving treatments for patients. We are preferred strategic partners with Regulatory Agencies, working as a cohesive global Regulatory Organization, fully using technology capabilities- aligned with the innovative trends in the environment, driving continuous improvement and efficient Compliance.
What you’ll do
The CMC Regulatory Affairs Associate Director will provide device regulatory strategy, operational, tactical, and decision-making expertise for digital therapeutic and medical device software programs, including during product development, global launch, and post approval lifecycle management. They will represent Device Regulatory as required in cross-functional teams across the business for example Digital Therapeutic Development teams, Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, and Clinical Supply Chain/Global Supply Teams.
Additionally, the CMC Regulatory Affairs Associate Director may support development of new internal guidance, policy, and processes and will effectively manage the operation of medical device, digital therapeutic, and IT asset classification processes to support proactive management of AZ digital product strategies (and other processes as may be needed).
Provide device regulatory expertise for digital therapeutics and medical device software across the business functions. May lead key business improvement initiatives & sit on external industry groups.
Provide strategic digital device regulatory expertise and direction for submissions across the lifecycle of a product.
Where necessary, lead device regulatory related interactions with Health Authorities globally.
Accountable for the provision of expert device regulatory strategic guidance in support of Operational initiatives, for example complex/accelerated projects and/or post approval changes.
Contribute to or lead policy setting and strategy development in the device regulatory environment within or external to AstraZeneca for digital therapeutic and medical device software products.
Lead knowledge sharing and provide mentorship both within CMC RA and wider business functions. Lead/contribute to Community of Practises across the groups or within a business unit.
Accountable for managing high level risks by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
Provide AZ technical functions clear, concise guidance on current digital device regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to devices.
Support the implementation of agile and novel approaches in device regulatory submissions that drive new ways of thinking to enhance flexibility efficiency and flexibility.
Participate and /or lead due diligence teams as necessary.
Lead /contribute to cross SET non-drug projects and act as business owner for business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.
Education, Qualifications, Skills and Experience
Essential for the role:
Degree /PhD or equivalent professional qualification in a science or technical field such as engineering, pharmacy, biology, chemistry or biological science.
Significant experience in the combination product or medical device industry, with preference for direct experience with medical device software products
Demonstrated practical experience in medical device regulatory affairs [e.g. IDE/510(k)/PMA filings, Notified body interactions, application of device quality management system, software validation, human factors, and design verification/validation requirements]
Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy
Stakeholder & Project management
Professional capabilities: Regulatory knowledge
Desirable for the role:
Post graduate qualification
Business, financial and supply chain understanding/ awareness
Quality Risk Management
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer.
Where can I find out more?
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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 authorization and employment eligibility verification requirements.