Senior Regulatory Affairs Director at AstraZeneca

Cambridge, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

28 Feb, 26

Salary

0.0

Posted On

30 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Leadership, Strategic Thinking, Program Management, Risk Mitigation, Drug Development, Communication, Collaboration, Regulatory Strategy, Scientific Understanding, Clinical Understanding, Innovation, Coaching, Performance Feedback, Market Access, Therapeutic Areas

Industry

Pharmaceutical Manufacturing

Description

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. 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 exceptional skills with those of people from all over the globe. As a Senior Regulatory Affairs Director you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. R&D Oncology drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. What you'll do: As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. You will show strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs. You will lead the planning and construction of the global dossier and core prescribing information. You will conduct regulatory risk planning and mitigation. You will leads the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement. You will be accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures. You will be accountable for product maintenance, supply and compliance activities associated with marketed brands. You will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. You will partner with marketing company and regional regulatory affairs staff to influence developing views/guidance. You will lead the regulatory staff working, provide leadership and participate in skill-development, coaching, and performance feedback. Essential Requirements: Advanced degree in a science related field and/or other appropriate knowledge/experience. Must have previous experience in leading Major Health Authority interactions. Significant experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas. Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred. Proven leadership and program management experience. Ability to think strategically and critically evaluate risks to regulatory activities. Ability to work strategically within a complex, business critical and high profile development program. Successful contribution to a major regulatory approval at a global level. A scientific and clinical understanding of the regulatory sciences. Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. Recognizing the importance of individualized 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. Date Posted 26-Nov-2025 Closing Date 30-Dec-2025 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.

Responsibilities

As the Senior Regulatory Affairs Director, you will lead the development and implementation of the global regulatory strategy for complex products. You will ensure rapid approval and advantageous labeling while managing regulatory risks and milestones.