AstraZeneca
Senior Regulatory Affairs Director
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Senior Regulatory Affairs Director
Introduction to Role
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.
Accountabilities
- 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.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
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 (e.g. 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. Date Posted 10-Jul-2026 Closing Date 24-Jul-2026
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills