CMC Regulatory Affairs Manager

Introduction to role:

Are you ready to make a difference in the world of medicine? At AstraZeneca, we are committed to putting patients first and addressing unmet needs globally. As a CMC Regulatory Affairs Manager, you'll be part of a dynamic team that spans the product lifecycle, crafting regulatory strategies for the development, manufacture, and testing of our medicines. We interpret, anticipate, and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies. If you're swift to action, confident in leadership, collaborative, and curious about the potential of science, this is your opportunity to shine!

Accountabilities:

• Manage the timely preparation and delivery of CMC contributions to regulatory submissions throughout the product lifecycle.
• Ensure submission-ready international CMC modules are delivered to stakeholders in compliance with AstraZeneca systems and procedures.
• Maintain and communicate Health Authority approval status.
• Develop expertise in regional regulatory requirements to ensure compliance of CMC submissions.
• Adapt project management strategies to changing situations for on-time delivery.
• Share learnings from projects with colleagues and within functions.
• Support strategies employing regulatory intelligence to optimize submission content.
• Participate in regulatory execution meetings and update the international 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 the product lifecycle stage.

Essential Skills/Experience:

• Bachelors degree in Science, Regulatory Sciences or Pharmacy
• 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
  

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.

AstraZeneca empowers its employees with tools for innovation and originality. Here, you are encouraged to take smart risks and break barriers, fostering an environment where creative ideas lead to innovative regulatory approaches. Our inclusive and diverse setting allows you to thrive, drawing on collective knowledge to deliver better solutions for patients and the business. With a rich pipeline and global opportunities, you have the autonomy to be an agent of change.

Ready to join us on this exciting journey?

Apply now and be part of a team that's transforming science into life-changing solutions!

Date Posted

26-jun-2025

Closing Date

16-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.

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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.