CMC Regulatory Affairs Director - Biologics
Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Would you like to apply your expertise to impact the CMC Regulatory Affairs team in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca are pioneers in science, we strive to lead in our disease areas and transform patient outcomes. Our company’s aim is to deliver 20 new medicines and be carbon negative by 2030.
Here at AstraZeneca, we are looking to enable you to be the best you can be. We thrive in our inclusive and ambitious environment. We draw on our knowledge to take thoughtful risks and uncover creative ways to better deliver for our patients and our business.
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 and Device Regulatory Strategies.
As a CMC Regulatory Affairs Director, you will provide appropriate CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for biologic projects and complex product ranges from development phase through to global launch and post approval lifecycle management. You will represent CMC in networks across the business including Pharmaceutical Development Project teams, Global Regulatory Strategy Teams, Global Supply Teams, Global Quality and Operations. The role holder may lead development of new guidance, policy, and processes. They will also be a key partner for identified customer functions to facilitate high quality partnerships within and external to AstraZeneca. The role holder will support and coach across CMCRA for products/projects and /or specialist areas. The Regulatory Affairs Director will have an in depth understanding in the complexity and challenges that are required for Biologic Product Dossier submissions and have proven project management skills.
Major Duties and Responsibilities:
Provide Biologic CMC RA expertise across the business functions. May lead key business improvement initiatives. May sit on external industry groups.
Provide operational, tactical, and strategic Biologic CMC RA expertise and direction for CMC submissions across the lifecycle of a product.
Where necessary lead CMC related interactions with Health Authorities globally.
Accountable for the provision of expert 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 CMC RA environment within or external to AstraZeneca.
Lead knowledge sharing and provide coaching 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 risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.
Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendation and decisions on regulatory issues relating to CMC.
Support the implementation of agile and novel approaches in CMC Dossier Management 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.
PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science
A minimum of 7 years relevant experience
Breadth of knowledge of biologic product manufacturing, project, technical and regulatory project management.
Strong understanding of regulatory affairs globally
Direct Regulatory Affairs CMC experience with submissions for biologic and biotechnology derived products
Stakeholder & Project management
Professional capabilities: Regulatory knowledge
Post graduate qualification
Business, financial and supply chain understanding/ awareness
Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
This position can sit at our Macclesfield or Cambridge, UK; Gaithersburg, MD, USA; Mississauga, Canada; Södertälje or Gothenburg, Sweden locations.
If this sounds like the type of organization where you would like to grow your career and make a real difference to patients then we would like to hear from you; apply today!
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.