Regulatory Affairs Manager

Job title: Regulatory Affairs Manager

Introduction to role:

Are you ready to turn complex global regulations into faster approvals that put life-changing medicines in patients’ hands? In this role, you will lead regulatory strategy and execution across development and lifecycle, guiding submissions and health authority interactions to secure timely registrations. You will translate evolving requirements into decisive plans that align teams, reduce risk, and enable confident, on-time delivery. Can you see yourself shaping the path from first dossier outline to final approval while building capability around you?

Accountabilities:

• Regulatory Strategy: Develop and implement regulatory strategies for product registration, labeling, post-approval changes, and lifecycle management to accelerate approvals and optimize product value.

• Submission Management: Lead or coordinate the preparation, review, and submission of regulatory dossiers, variations, renewals, and responses to questions, delivering right-first-time quality and region-specific compliance.

• Health Authority Engagement: Plan, support, or lead agency communications, including meeting requests, briefing documents, and rapid, clear responses and follow-up that build credibility and trust.

• Compliance and Standards: Ensure all activities align with regulations, guidance, company policies, and submission standards; champion inspection readiness and a culture of quality.

• Cross-Functional Collaboration: Partner with internal teams to gather required documentation, align regulatory plans with project milestones, and resolve issues quickly to protect timelines.

• Labeling Support: Contribute to the development, review, and maintenance of product labeling, artwork, and regulatory text to ensure accuracy and alignment with scientific and commercial objectives.

• Change Control and Lifecycle Management: Assess regulatory impact of manufacturing, quality, safety, or labeling changes; define and deliver required submissions to maintain market continuity and product compliance.

• Planning and tracking: Build and maintain submission timelines, regulatory risk assessments, and documentation that enable transparent decision-making and inform business planning.

Essential Skills/Experience:

• Bachelor’s degree in pharmacy.

• Strong experience in regulatory affairs

• Strong understanding of relevant regulatory frameworks and other applicable requirements.

• Strong written and verbal communication skills, including the ability to prepare clear regulatory documentation and influence stakeholders.

• Strong Project management skills with the ability to manage multiple deadlines, coordinate contributors, and escalate risks appropriately.

• Strong focus on details, accuracy, documentation quality, and compliance.

Desirable Skills/Experience:

• Strategic thinking

• Regulatory judgment

• Stakeholder management

• Planning and prioritization

• Risk assessment

• Problem solving

• Cross functional collaboration

• Decision making

Why AstraZeneca?

Here you will work with specialists who are empowered to influence decisions across the enterprise, combining bold ideas with disciplined delivery to move fast without compromising on quality. We bring unexpected teams together—policy shapers, scientists, technologists, and regulatory experts—to challenge assumptions and spark better solutions. You will be encouraged to keep learning, deepen your expertise, and explore new areas with coaching and mentorship that match your ambition. We value kindness alongside ambition, and we balance a dynamic, change-driven environment with the rigour required by government procedures—so your work directly accelerates patient access while advancing your career.

If you are ready to lead regulatory strategy that turns science into approvals and measurable patient impact, take the next step and shape what comes next with us today!

Date Posted

Closing Date

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.