CMC RA Reg Manager Submission Excellence and Project Management

Job Title: CMC RA Reg Manager Submission Excellence and Project Management

Career Level: D

Introduction to 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.

Essential Skills/Experience:

• Bachelors degree in Science, Regulatory Sciences or Pharmacy

• 8+years of relevant experience

• Breadth of knowledge of manufacturing, project, technical, and regulatory management

• IT Skills

• Partner & Project management

• Professional capabilities: Regulatory knowledge

Desirable Skills/Experience:

• Masters degree in Science, Regulatory Sciences or Pharmacy

• 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 sophisticated biologic products

• Understanding of regulations and mentorship governing the manufacture of biotechnology products, especially monoclonal antibodies

• Lean capabilities

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our uoutstandingboldious world.

At AstraZeneca, we are driven by our passion for science. We are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration across academia, biotechs, and industry. We offer opportunities for continuous learning and career development as we push the boundaries of science to deliver life-changing medicines.

Ready to make an impact? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.