About the role
Are you ready to take on a pivotal role in the production of Chemistry, Manufacturing, and Control (CMC) documentation for a range of products? As a CMC RA Reg Manager, you will project manage global CMC regulatory submissions, ensuring that all project activities and documentation meet the required standards throughout the product lifecycle. You will lead and contribute to regulatory CMC components of business-related projects, maintaining effective communication with stakeholders and project team members to ensure timelines and regulatory commitments are met. Your expertise will help apply global CMC regulations and guidance within AstraZeneca, contributing to the development of new policies and processes.
Accountabilities
Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorization applications, and post-approval activities.
Deliver "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
Ensure publishing tools are in place and perform timely publishing of the CMC sections.
Lead/represent PT&D and Pharm Sci on cross-functional work streams.
Document maintenance and communication of Health Authority approval status.
Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
Adapt to changing situations to ensure on-time delivery through project management expertise.
Proactively share learning from own projects with colleagues.
Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) when applicable, advising project teams.
Provide advice, training, and mentorship to other team members.
Train others in procedures and practices relating to ANGEL within PT&D and Pharm Sci.
Raise change requests (ANGEL), manage, escalate, and input into the cross-functional vote.
Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence to optimize proposed submission content.
Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.
Contribute to business process optimization activities to reduce waste and ensure efficiency.
Evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.
Apply GxP principles according to the stage of the product lifecycle.
Lead change as assigned.
Understand the application of appropriate risk management across own activities.
Demonstrate research skills in understanding regulations and mentorship from different regulatory agencies.
Conduct activities and interactions consistent with Things We Value and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
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