CMC RA Reg Manager Submission Excellence and Project Management

Are you ready to manage all aspects related to the production of Chemistry, Manufacturing, and Control (CMC) documentation for designated product ranges? As a CMC RA Reg Manager, you will ensure the timely preparation and delivery of CMC contributions to regulatory submissions, including clinical programs and marketing authorization applications. You will lead the regulatory CMC components of business-related projects, ensuring that project activities and documentation meet required standards across the product lifecycle. Effective communication with stakeholders and project team members is key to ensuring relevant timelines and regulatory commitments are met. Join us in applying global CMC regulations and guidance within AstraZeneca, contributing to the development of new guidance, policy, 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 all post-approval activities.
• Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
• Ensure that publishing tools are in place and perform publishing of the CMC sections in a timely manner.
• 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.
• Project management expertise with the ability to adapt to changing situations to ensure on-time delivery.
• Proactively share learning from own projects with other colleagues.
• Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) contributing to and 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 & input into the cross-functional vote.
• Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence and optimizing 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.
• Continually 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.
• Responsibility for change management as assigned.
• Understand application of appropriate risk management across own activities.
• Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.
• Conduct activities and interactions consistent with Company Values 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.
• Follow processes and work to standards, identify and solve problems, define and implement improvements.

Essential Skills/Experience

• Bachelors degree in Science, Regulatory Sciences or Pharmacy.
• 2 years 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.

Desirable Skills/Experience

• Masters degree in Science, Regulatory Sciences or Pharmacy.
• 4 years experience in Regulatory/Drug development (Industry or Health Authority).
• Knowledge of the drug development process and regulatory submissions.
• Understanding of current regulatory CMC requirements.
• Direct/indirect Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or complex biologic products.
• Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies.
• Lean capabilities.

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