International Chemistry, Manufacturing and Control (CMC) Regulatory Affairs Manager

International CMC Regulatory Affairs Manager I

Job Title: International CMC Regulatory Affairs Manager I

Global Career Level: D1

Introduction to role

This role manages the end-to-end delivery of Chemistry, Manufacturing and Control (CMC) documentation for assigned product ranges, ensuring regulatory submissions meet business needs and patient expectations across the full product lifecycle. It involves leading and coordinating international CMC regulatory submissions, so that activities, data and documentation are delivered to the right quality, on time and in line with global requirements. The role leads and contributes to the CMC regulatory components of key business projects, maintaining strong communication with stakeholders and project teams so that timelines, risks and regulatory commitments are clearly understood. It also ensures international CMC regulations and guidance are applied consistently, while helping to shape new internal guidance, policy and processes that raise standards and improve ways of working.

Accountabilities

Lead the planning, preparation, authoring and delivery of CMC content for marketing authorisation applications and post-approval submissions, ensuring high-quality, compliant dossiers.

Coordinate and project manage international CMC submission activities, tracking progress, managing risks and adapting plans to meet changing priorities and regulatory expectations.

Maintain clear documentation of Health Authority approval status and commitments, ensuring information is accurate, current and accessible to relevant stakeholders.

Build and deepen expertise in regional regulatory requirements to secure compliance of CMC submissions and anticipate regulatory trends.

Share learnings from projects across teams to strengthen collective regulatory knowledge and improve future submissions.

Support the use of fit-for-purpose content by applying regulatory intelligence to optimise submission strategies and outcomes.

Participate in regulatory execution and delivery meetings, providing concise updates and insight to the CMC team.

Contribute to business process optimisation initiatives that reduce waste, streamline workflows and enhance efficiency.

Continuously develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments.

Apply appropriate GxP principles according to product lifecycle stage, ensuring robust quality and compliance.

Take responsibility for assigned change management activities, assessing impact and ensuring changes are implemented in a controlled way.

Apply risk management principles across activities to identify, assess and mitigate potential issues.

Demonstrate strong research skills in interpreting regulations and guidance from multiple agencies, translating them into practical CMC strategies.

Operate in line with AstraZeneca Values, Code of Ethics and all relevant policies and standards, completing required training on time and reporting potential non-compliance.

Follow standard processes, actively identify and solve problems, and define and implement improvements that drive continuous enhancement of regulatory performance.

Essential Skills/Experience

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

• Minimum 7 years of Relevant experience from biopharmaceutical industry, or other relevant experience

• Breadth of knowledge of 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 medicinal products

• Understanding of regulations and guidance governing the manufacture of medicinal 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.

AstraZeneca offers the chance to work on meaningful science that directly shapes how life-changing medicines reach patients worldwide, with a rich pipeline that spans the full drug development journey. Regulatory professionals collaborate across locations, therapy areas and external partners to solve complex problems, use data and analytics to shorten development cycles, and pioneer modern regulatory approaches for niche patient populations. It is an inclusive environment where diverse perspectives are valued, people are trusted with real responsibility, encouraged to ask questions, try new ideas and act as agents of change, while benefiting from global opportunities to grow skills, explore different roles and build a long-term career.

Ready to step up, drive impactful CMC submissions and help bring transformative medicines to patients faster? Apply now.

Date Posted

13-May-2026

Closing Date

16-May-2026

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.

Experience Level

Entry Level