International CMC Regulatory Affairs Manager

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Chemistry, Manufacturing, and Controls (CMC)

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.

What you will do :

The role holders effectively manage the delivery, compilation and production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs for the international region and filings according to accelerated wave plans. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.

They will ensure the application of international CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, policy, and processes.

• Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including marketing authorisation applications and all post approval approval activities
• Accountable for delivering “submission ready” international CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
• Documenting maintenance and communication of Health Authority approval status.
• Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
• Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
• Ensure the learning from own projects are shared with other colleagues/within the functions.
• Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content
• Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the international CMC team.
• Contribute to business process optimisation activities to reduce waste and ensure efficiency.
• Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.
• Apply GxP principles according to the stage of product lifecycle

Essential Requirements

• Bachelors degree in Science, Regulatory Sciences or Pharmacy
• Experience in Regulatory / Drug development (Industry or Health Authority)
• Breadth of knowledge of manufacturing, project, technical and regulatory management.
• IT Skills
• Stakeholder & Project management
• Professional capabilities: Regulatory knowledge

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.