Regulatory Affairs Associate Director

Welcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, big dreamers, and collaborators who work 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 are currently seeking a Reg Affairs Associate Director for our Oncology R&D department. This is an exciting opportunity to turn our pipeline into reality and impact unmet patient needs.
Chemistry, Manufacturing, and Controls (CMC)
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
What you will do
Provide International regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within International Regulatory Affairs and AZ technical functions. Will typically have responsibility for new chemical entities / line extensions/post marketing activities.
Ensure project activities are delivered to a high standard, agreed timelines, and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
Define the strategy and content of International CMC submissions and review and approve regulatory CMC documents for assigned projects. Such submissions could include marketing authorisation applications, line extensions, Variations, Annual Reports or Licence renewals for marketed products.Working to ensure the content of submission documentation is aligned with the agreed cross-functional strategy, with appropriate consideration of the desire for subsequent operational flexibility.
Represent international CMC RA on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated. Ensure effective networks across the business functions including marketing companies manufacturing sites, Quality, and site technical functions as appropriate for assigned projects or products.
Contribute to knowledge sharing, eand provide coaching both within CMC RA and across appropriate functional area’s
Facilitate/support CMC related interactions with Health Authorities within the international region
Manage the provision of international regulatory strategic guidance in support of operational initiatives
Manage and communicate high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
Provide AZ technical functions clear, concise guidance on current international CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC, including proactive management and mitigation.
Responsibility for change management as assigned.
Apply GxP principles according to stage of product lifecycle
Highlight resource needs for product as appropriate for effective planning purposes.
Contribute to cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities / management of regulatory information and ensure regulatory compliance on behalf of AZ.
Essential Skills/Experience:
Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
Breadth of knowledge of manufacturing, project, technical and regulatory management.
Understanding of regulatory affairs globally.
Stakeholder & Project managementProfessional capabilities: Regulatory knowledge
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. Were motivated by science, success and achieving our goals in a way thats novel and thoughtful.
Are you ready to make a difference? Apply today!
Date Posted 15-may-2024
Closing Date 05-jun-2024
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.
AstraZeneca

Fecha de publicación: 17/05/2024