CMC Regulatory Affairs Associate Director

Are you passionate about the application of science to deliver life changing medicines? Join, a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC Regulatory Strategies.

We are now looking to recruit a CMC Regulatory Affairs Associate Director to join our team.

What you'll do
The Associate Director is responsible for effectively managing projects or complex product ranges across the portfolio throughout the product lifecycle to deliver the needs of both the AZ business and the customer. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards and timelines as well be as drive the delivery of the regulatory CMC components of business-related projects. You will be accountable for interfaces with CMC Product leads, proactively partner with stakeholders across AZ organisation to help deliver and implement innovative risk based regulatory strategies and ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, policies, and processes.

With this in mind, you have effective levels of interactive communication with stakeholders and project team members including CMC Regulatory Managers directly advising and influencing those by demonstrating strong project management and tactical delivery expertise.

Additional to this you will:

* Manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorisation applications and all post approval activities
* Project manage complex global CMC regulatory programs ensuring that project activities and documentation are delivered to the required high standard, agreed timelines, and meet the business requirements, compliance with the registered dossier content through maintenance and communication of Health Authority approval status.
* Lead CMC submission management teams. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
* Highlight resource needs for product as appropriate for effective planning purposes.
* Apply GxP principles according to the stage of product lifecycle Responsibility for change management as assigned.
* Lead /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.
* Has expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
* Apply an appropriate level of risk management across activities.
* Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.

Essential for the role

* Degree 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.
* Strong understanding of regulatory affairs globally
* Stakeholder & Project management experience with the ability to adapt to changing situations to ensure timely delivery

Desirable for the role

* Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products
* Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
* Professional Capabilities such as: Lean Approach, Quality and Compliance Management and Quality Risk Management

So, what's next?
Are you already imagining yourself in this position? Good, because we can't wait to hear from you!

Welcome with your application; CV and cover letter, no later than March 6th, 2023.