Head of International CMC Regulatory Affairs

The Head of (Executive Director) International CMC Regulatory Affairsreports to the VP International Regulatory Affairs and is accountable for leading a team of Regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy delivery and execution of International CMC Regulatory strategy and leadership across the product lifecycle.The International region is the largest most diverse and fastest growing region in AstraZeneca. It has over 28000 employees across more than 75 markets spanning many different cultures and languages. Areas it includes are: Middle East & Africa South America Asia and Australasia.We are seeking a Regulatory Quality and Compliance expert to contribute to the strategic direction and leadership of the International CMC Regulatory Affairs function. Responsible for development and delivery of the International CMC Regulatory strategy for all biologics or synthetic products across the commercial lifecycle.What You Will Do:The role possesses strategic leadership skills and has the depth of knowledge and experience within the CMC Regulatory environment. Influential in cross functional discussions with relevant senior internal and external stakeholders to deliver the overarching international CMC regulatory strategy for AstraZenecas medicines portfolio. This is across development and commercial products to secure approval ensure continuity of drug supply and maintain regulatory compliance. The position has significant impact on achievement of AstraZenecas financial and business goals. You will partner with Research Development & Operations experts to build innovative strategies for development of current and future drug portfolio and identify activities to define effective regulatory strategy on a global basis. You will contribute to the strategic development of the International CMC Regulatory Affairs function collaborating with senior colleagues across Regulatory Affairs R&D and Global Operations to ensure overall strategic alignment to meet AZs portfolio goals. You will work with Operations Supply Chain leadership to define strategy and priorities for optimisation of commercial supply chain for a portfolio of products. Attend Supply Committee as needed providing Regulatory input into proposals impacting global supply.Essential Skills/Experience: Experience in Regulatory Affairs with focus on CMC. Other relevant experience in the pharmaceutical industry for example in CMC Development Quality Control Manufacture or relevant roles in Regulatory Agency Strong strategic thinking and influencing skills at all levels across cultural interfaces Significant experience in leading and developing teams of people Ability to establish and foster excellent cross functional collaborations and communicate at multiple levels of the organization Strong leadership skills working in an international environment Strong communication and interpersonal skills Develops People and Organisation builds capability for the organisationDesirable Skills/Experience: Experience of leading or contributing to significant change programs Experience of Product Development DPOM and associated resource requirements Extensive in-depth knowledge of regulatory procedures and processesWhy AstraZenecaAt AstraZeneca we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on products we 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. Turn our pipeline into reality to impact patients Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process.Location: Cambridge or Macclesfield UKSalary: Competitive Excellent BenefitsNext StepsAre you ready to step up and take ownership of your work solutions for the business and your personal career development Apply now and join us in our mission to bring life-changing medicines to peopleWhere can I find out moreOur Social MediaFollow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Date Posted03-Dec-2025Closing Date12-Dec-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:Director Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1