CMC REGULATORY AFFAIRS MANAGER

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.
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture, and testing of all our medicines.
With our expertise, we interpret, anticipate, and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
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 lifecycle.
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 the development of new guidance, policy, and processes.
Accountabilities.
- 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 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 Skills/Experience.
- 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.
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