CMC RA Reg Manager Submission Excellence and Project Management

Are you ready to lead and manage the production of Chemistry, Manufacturing, and Control (CMC) documentation for a range of innovative products? As a CMC RA Reg Manager, you will oversee global CMC regulatory submissions, ensuring that all project activities and documentation meet the highest standards throughout the product lifecycle. You will play a crucial role in contributing to and leading the regulatory CMC components of business-related projects. Effective communication with stakeholders and project team members will be key to ensuring timelines and regulatory commitments are met. Join us in applying global CMC regulations and guidance within AstraZeneca, while also 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 all 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 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.
- 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) contributing to and advising project teams where applicable.
- Provide advice, training, and mentorship to other team members.
- Manage change requests (Veeva), 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.
- 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.
- Responsible 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.

Essential Skills/Experience

- Bachelors degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
- IT Skills
- Stakeholder & Project management
- Professional capabilities: Regulatory knowledge

Desirable Skills/Experience

- Masters degree in Science or technical field such as pharmacy, biology, chemistry or biological science.
- Direct Regulatory Affairs CMC experience with submissions for Biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products
- Knowledge of the drug development process and regulatory submissions
- Understanding of current regulatory CMC requirements
- Understanding of regulations and guidance governing the manufacture of biotechnology products
- Lean capabilities

When we put unexpected teams in the same room, we unleash 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 unique and ambitious world.

At AstraZeneca, we follow the science with curiosity and determination. Our commitment to Oncology is driven by our ambition to eliminate cancer as a cause of death. With cutting-edge science and technology, we aim to deliver breakthroughs that transform patient outcomes. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.

Ready to make a difference? Apply now!