Senior Regulatory Affairs Director in Cambourne

The Senior Regulatory Affairs Director (RAD) leads the development and implementation of global regulatory strategy for one or more products of high complexity and visibility, and may serve as Franchise Global Regulatory Lead (GRL) on complex programmes with multiple indications. Where applicable, this role also operates in a dual capacity, serving as a regional lead based on location, in addition to GRL responsibilities.

Central to this role is ensuring that regulatory strategy delivers rapid approvals with competitive labeling, aligned to the properties of the product(s) and the needs of the business, markets, and patients. The Senior RAD provides team leadership across a large Global Regulatory Strategy Team, including coaching and mentorship, while driving global regulatory deliverables in line with GPT goals.

Externally, the Senior RAD builds and maintains relationships with key regulatory stakeholders, leveraging these to sustain competitive advantage. This is a visible position, recognised as a senior leadership role within the Regulatory Community.

Responsibilities

• Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of high complexity and/or spanning multiple indications.
• This includes providing Regulatory leadership on franchise products with multiple indications and development programs.
• May serve in dual-role as GRL and regional RAD.
• Ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
• Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
• Participate in coaching and performance feedback to members of your GRST.
• Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
• Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and accountable for all Regulatory activities.
• Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.
• You will lead preparation of the regulatory strategy document and target product labeling.
• Demonstrate strategic leadership skills thereby contributing to effective product development.
• Lead, participate, and promote non-project functional or cross-functional initiatives and engage externally on the corresponding topics as needed.
• Lead the development of novel regulatory tools and technology.
• Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.
• Accountable for product maintenance, supply and compliance activities associated with marketed brands.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
• May have line management responsibilities.

Essential Skills/Experience

• An advanced degree in a scientific discipline with extensive relevant experience/knowledge.
• Deep understanding of global regulatory science and integration with program strategy.
• Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Proven experience leading regulatory, cross-functional teams, and stakeholder management.
• Successful leadership of at least one global regulatory marketing approval as GRL across major regions (US and EU) including leading response team and labeling negotiations.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Previous experience in leading major Health Authority interactions.
• Excellent oral, written, and presentation skills.
• Strong organisational skills.
• Ability to work in a fast-paced environment in a hands-on fashion.
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.

Desirable Skills/Experience

• Experience with FDA advisory committee and CHMP oral explanation.
• Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through coaching or mentorship.
• Contribution to non-project business initiatives (at a portfolio or cross functional level).
• Experience in Oncology (small molecules and biologics) is preferred.

Why AstraZeneca

Join a science-led company advancing life-changing medicines with urgency and precision, where bold thinking meets rigorous execution to solve complex health challenges. Here, unexpected teams come together to spark new ideas, and diverse perspectives are not just welcomed but relied upon to unlock smarter, faster paths for patients.

Recognising the importance of individualised flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.