Head International CMC Regulatory Affairs

At 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 lifechanging 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 groundbreaking medicines across diverse therapy areas and at all stages of the development process.

TheHead (Senior Director) International CMC Regulatory Affairsreports to the Executive Director International Regulatory Strategy and is accountable for andleading a team of regulatory professionals (710 direct reports at Director level and 3040 indirect reports) responsible for strategy delivery and execution of international CMC Regulatory strategy and leadership across the product lifecycle.

Theinternational regionis 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: South America Africa Asia and Australasia.

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.

What You Will Do:
You willpartner 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 organisation

Desirable Skills/Experience:
Experience of leading or contributing to significant change programs
Experience of Product Development DPOM and associated resource requirements
Extensive indepth knowledge of regulatory procedures and processes

Next Steps

Are 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 lifechanging medicines to people!

Location:Cambridge UK

Salary:Competitive Excellent Benefits

Where can I find out more

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Date Posted

07May2025

Closing Date

28May2025Our 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.