Regulatory Affairs group Director- Intl

Job Title: Regulatory Affairs Group Director

GCL: F

Introduction to role:

Within International Regulatory Affairs, Regulatory professionals take innovative approaches to bring life-changing medicines to patients in international markets. Working across the AstraZeneca pipeline and business, the team accelerates regulatory approvals for new medicines in international markets as efficiently and effectively as possible so that no patient waits. An opportunity has now arisen for a Regulatory Affairs Group Director to join the International Regulatory Affairs team, leading a group of up to 15 people who drive regulatory submissions to international regulatory agencies worldwide. This role uses deep regulatory expertise to guide team members through complex frameworks, securing first Marketing Authorisation Application approvals, clinical line extensions and lifecycle maintenance activities in international markets. With a fast-moving pipeline and international acceleration as a priority, this position calls for strong leadership, clear prioritisation and a sharp understanding of International Regulatory Affairs to keep work on track and inspire others!

Accountabilities:

• Lead, coach and line manage a team of up to 15 regulatory professionals, setting clear expectations and enabling high performance.
• Develop organisational capability for international markets, promoting knowledge sharing and a continuous improvement approach as a recognised subject matter expert.
• Attract and recruit talent, acting as an ambassador for International Regulatory Affairs and clearly articulating Regulatory Affairs Manager roles and responsibilities to stakeholders.
• Contribute as a senior member of the International Regulatory Affairs community to shape strategy, direction and efficient operations, including defining and delivering departmental performance targets.
• Design and implement resourcing solutions for therapy area projects in collaboration with the International Senior Regulatory Affairs Director, ensuring cost-effective and flexible resource management aligned with international market priorities.
• Ensure personal work and that of direct reports aligns with AstraZeneca standards, processes, group policies and corporate responsibilities.
• Apply in-depth regulatory knowledge of RAM roles, Submission Excellence and the Regulatory Operating Model to support individuals at global and regional levels, ensuring timely delivery of project objectives to the right quality.
• Lead continuous improvement initiatives within International Regulatory Affairs and represent the function on cross-functional initiatives such as NGS.
• Drive the development of pioneering RAM capabilities, systems and process improvements that deliver efficiency gains across International Regulatory Affairs.
• Influence the external image of the business and represent AstraZeneca in industry associations and international advocacy programmes where appropriate.

Essential Skills/Experience:

• 15+ years of Extensive regulatory experience within the biopharmaceutical industry and/or experience at a health authority.

• Previous line management and project resourcing experience within AstraZeneca

• Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle with particular emphasis on new Marketing Authorisation Applications (MAAs) & Clinical Line Extensions (CLEs) and Lifecycle Maintenance (LCM) for International markets.
• Proven successful leadership of multi-disciplinary, cross-functional teams and extensive project management experience
• Thorough knowledge of Int’l Regulatory Affairs as a Subject Matter Expert
• Proven ability to drive and implement change and improvement projects
• Strong influencing, collaborator management and negotiating skills.

• Excellent written and verbal communication skills

• University Degree in Science or a related field

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 an environment where regulatory leaders are trusted to build strategy from early development through to approval, stepping beyond traditional boundaries to influence decisions, challenge assumptions and turn sophisticated science into real-world impact for patients. Independent thinking is encouraged, curiosity is celebrated, and there is strong support for continuous learning through clear development paths and initiatives such as a Regulatory academy. Collaboration across therapy areas, willingness to new technology and data-driven approaches all combine to create a setting where bold ideas are tested, balanced risks are managed thoughtfully and regulatory professionals can see the tangible results of their work in accelerated approvals and better treatment options.

Ready to lead a high-performing team, challenge conventional regulatory thinking and help bring transformative medicines to patients worldwide? Apply now.

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.