Would you like to apply your global Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?

At AstraZeneca, we do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing! We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) developing and implementing the global strategy on complex oncology programs with multiple indications. In addition, the SRAD has the ability to function in dual capacity by serving as the regional lead based on location. The SRAD establishes external relationships with key stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the Regulatory community.

Within Oncology Regulatory Science and Strategy (ORSS), we bring hope and solutions to patients with unmet needs across the globe. Our regulatory professionals take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and optimally as possible.

What you'll do:

• Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
• Ensure that the strategy is crafted to deliver approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
• Lead the assessment of emerging data against aspirations and update Leadership on project risks/mitigation activities.
• Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic advice and accountable for all regulatory activities.
• Own the delivery of all milestones on your team including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations.
• Demonstrate strategic leadership skills thereby contributing to effective product development.
• Promote novel regulatory initiatives internally, and engage externally on the corresponding topics. Lead the development of novel tools and technology.
• Partner and influence developing views/guidance on a global scale.

Minimum Requirements:

• Bachelor's degree in a science related field with at least 6 years of Regulatory experience or related knowledge/experience.
• Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval including leading strategy, response team, and labeling negotiations.
• Previous experience in leading global health authority interactions.
• Solid knowledge of regulatory affairs within multiple therapeutic including oncology areas in early and late development.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs with proven leadership experience.
• Ability to think strategically and critically and evaluate risks to regulatory activities.

Preferred Requirements:

• Advanced degree preferred.
• Experience in Oncology (small molecules & biologics).
• Previous experience with FDA advisory committee and EMA oral explanation is a plus.
• Previous experience working on due diligence activities and in a business alliance environment.
• Ability to work strategically within a sophisticated, business critical and high-profile development program.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

08-Apr-2024

Closing Date

07-May-2024Our 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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.