Compliance

• The Head of (Executive Director) 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 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.
• 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.

Head of International CMC Regulatory Affairs

Compliance Specialist II

Compliance Specialist