Greg Carr Email & Phone Number

• Lead an organization of 65 people consisting of 6 teams across multiple countries.• Responsible for all CMC deliverables for AstraZeneca’s small molecule cardio-vascular TA marketed product range, ensuring effective prioritization and resource balancing to meet business needs. Liaise with senior stakeholders to agree correct strategies.• Create and drive a culture of continuous improvement within the organization through the implementation of LEAN methodologies.• Design and review organizational strategies to meet future business needs.

• All the responsibilities for the Regulatory Account Manager role plus;• Responsibility for the management, development and co-ordination of a team of up to 13 professional regulatory and technical staff.• Support a continuous improvement program both at team and department level. Maintain LEAN principles within the team.• Manage resource within the team and ensure correct prioritisation is applied both within and across teams.• Lead the CMC aspects of the Operations Brexit Program. Identify project scope, determine resource needed and secure funding, keep stakeholders informed of current plans and progress.

• Provide regulatory CMC expertise to stakeholders to meet business needs for a variety of products.• Define CMC strategies and ensure projects are delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide. Ensure submission documentation is fit for intended purpose with appropriate consideration for operational flexibility.• Provide technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical or strategic planning. Provide expert recommendations and decisions on CMC issues including proactive risk management and mitigation.• Identify and plan resources needs for planning purposes.

Cheshire

• Project manage the delivery of worldwide regulatory submissions and approvals. Support a wide range of business critical projects, such as product transfers, process improvement projects and licence maintenance activities.• Provide technical CMC regulatory advice on submission strategy for execution of product lifecycle submissions.• Technical writing, review and submission of regulatory CMC documents.• Maintain licence to operate and ensure all relevant electronic systems are updated to ensure compliance. Raise awareness of manufacturing sites to regulatory changes and health authority approvals affecting the supply chain.• Work collaboratively with a range of global sites and functions to solve problems and deliver solutions to drive projects forward.

Cheshire, Uk

• Managing the delivery of chemistry projects, defining synthesis strategy, liaising with the wider project team to agree timelines according to project needs. • Working across discovery departments and functions in AstraZeneca to improve routes for chemical synthesis allowing efficient knowledge transfer to give a streamlined process.• Working with external partners to foster innovation to aid AstraZeneca discovery projects.• Strategic assessment and introduction of biotransformations capability into discovery at AstraZeneca. Building relationships with other sites and external organizations to help deliver project needs throughout the department.• Initiating and forming external collaborations with University departments to add value to the business and deliver projects.• Winning innovation awards for making significant improvements to projects allowing for substantial time and money savings.