Job Title: CMC RA Reg Manager Submission Excellence and Project Management
Career Level: D
Introduction to Role: 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 project activities and documentation meet required standards throughout the product lifecycle. You will lead and contribute to regulatory CMC components of business-related projects while maintaining effective communication with stakeholders and project team members to meet timelines and regulatory commitments. Your expertise will help apply global CMC regulations and guidance within AstraZeneca, contributing to policy and process development.
Accountabilities:
Manage the timely preparation (including potential authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products across their lifecycle, including clinical programs, marketing authorizations, and post-approval activities.
Deliver “submission ready” CMC modules in compliance with AstraZeneca systems and procedures, ensuring high-quality submissions.
Ensure publishing tools are available and perform timely publishing of CMC sections.
Lead or represent PT&D and Pharm Sci on cross-functional work streams.
Maintain documentation and communicate Health Authority approval statuses.
Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
Adapt to changing situations, ensuring on-time delivery through strong project management.
Share learnings from own projects with colleagues proactively.
Act as a Subject Matter Expert (SME) or Sub-Process Owner (SPO) as applicable, advising project teams.
Provide advice, training, and mentorship to team members.
Train others in ANGEL-related procedures and practices within PT&D and Pharm Sci.
Manage and escalate change requests (ANGEL), contributing to cross-functional decision-making.
Support the strategic development of fit-for-purpose content applying regulatory intelligence.
Participate actively in regulatory execution and delivery meetings.
Contribute to business process optimization activities to enhance efficiency.
Record and communicate Health Authority interactions, responses, and commitments proactively.
Apply GxP principles according to the product lifecycle stage.
Lead assigned change initiatives.
Apply appropriate risk management principles across activities.
Conduct activities in compliance with the AZ Code of Ethics, Policies, and Standards.
Complete all required training on time and report potential non-compliance issues.
Essential Skills/Experience:
Bachelor’s degree in Science, Regulatory Sciences, or Pharmacy.
8+ years of relevant experience.
Broad knowledge of manufacturing, project, technical, and regulatory management.
IT proficiency.
Strong partner and project management skills.
Deep professional regulatory knowledge.
Desirable Skills/Experience:
Master’s degree in Science, Regulatory Sciences, or Pharmacy.
Understanding of the drug development process and regulatory submissions.
Familiarity with current regulatory CMC requirements.
Direct or indirect Regulatory Affairs CMC experience with synthetics, biologics, or biotechnology-derived products such as monoclonal antibodies.
Understanding of regulations related to the manufacture of biotechnology products.
Lean capabilities.
Work Environment: In-person working provides the platform to connect, work at pace, and challenge perceptions, with an average expectation of three days per week in the office while allowing individual flexibility.
About AstraZeneca: AstraZeneca is driven by a passion for science, integrating data and technology with scientific innovations to achieve breakthroughs. The inclusive environment fosters collaboration across academia, biotechs, and industry. AstraZeneca offers opportunities for continuous learning and career development to push scientific boundaries and deliver life-changing medicines.
Diversity and Inclusion: AstraZeneca embraces diversity and equality of opportunity. Applications from all qualified candidates are welcome regardless of background, and the company complies with all relevant non-discrimination and employment laws.
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