Head of International CMC Regulatory Affairs in Cambridge

The Head of International CMC Regulatory Affairs reports 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 28,000 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 AstraZeneca’s 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 AstraZeneca’s 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 AZ’s 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 in-depth knowledge of regulatory procedures and processes.

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 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 UK

Salary: Competitive + Excellent Benefits

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 life-changing medicines to people!

Our 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.