CMC Regulatory Affairs Manager I

Job Title: CMC Regulatory Affairs Manager I

Global Career Level: D1

Introduction to role:

Are you ready to lead and innovate in the world of biopharmaceuticals? As a CMC Regulatory Affairs Manager I, you will project manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated biological product ranges for clinical and commercial phase for global markets. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. You will will contribute and lead the regulatory CMC components of business-related projects. You will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated. You will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, policy, and processes.

Accountabilities:

- Manage the timely preparation and delivery of CMC contributions to regulatory submissions throughout the product lifecycle.

- Ensure "submission ready" CMC modules are delivered to internal and external stakeholders in compliance with AstraZeneca systems.

- Document and communicate Health Authority approval status.

- Develop expertise in regional regulatory requirements to ensure compliance of CMC submissions.

- Adapt project management strategies to ensure on-time delivery.

- Share learnings from projects with colleagues and within functions.

- Support strategy to employ fit-for-purpose content using regulatory intelligence.

- Participate in regulatory execution meetings and provide updates to the CMC team.

- Contribute to business process optimization activities for efficiency.

- Evolve regulatory expertise through proactive communication of Health Authority interactions.

- Apply GxP principles according to product lifecycle stages.

- Manage change as assigned and apply risk management across activities.

- Demonstrate research skills in understanding regulations from different agencies.

Essential Skills/Experience:

- University degree in a science or technical field such as pharmacy, biology, chemistry, or biological science.

- Minimum 9 years of relevant experience from the biopharmaceutical industry or other relevant experience.

- Breadth of knowledge in manufacturing, project, technical, and regulatory management.

- IT Skills

- Stakeholder & Project management

- Professional capabilities: Regulatory knowledge

Desirable Skills/Experience:

- 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 products.

- Understanding of regulations governing the manufacture of biotechnology products, especially monoclonal antibodies.

- 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, innovation and creativity are at the heart of everything we do. We are committed to developing the next generation of therapeutics by fostering an environment where questioning minds thrive. Our diverse teams reflect the communities we serve, enabling us to unlock industry-leading growth through shared perspectives. With a focus on lifelong learning and development, we empower our employees to take smart risks and push boundaries. Join us in making a meaningful impact on medicine, patients, and society.

Ready to make a difference? Apply now and be part of our journey to pioneer the future of healthcare!

Date Posted

18-Jul-2025

Closing Date

24-Jul-2025

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.

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 authorisation and employment eligibility verification requirements.