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For Companies At a Glance
- Tasks: Lead regulatory submissions and manage project deliverables in a dynamic environment.
- Company: Join AstraZeneca, a leader in biopharmaceutical innovation and diversity.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in drug development while collaborating with diverse teams.
- Qualifications: Degree in Science and regulatory experience in the biopharmaceutical industry.
- Other info: Inclusive culture that values diverse perspectives and promotes career advancement.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Accountabilities
- Generate Competitive Licences (0-40%)
- Regulatory Compliance & Governance (0-10%)
- Commercial Support (0-15%)
- Formulate and Influence Regulatory Strategy (0-15%)
- Lead the Organisation and Improve productivity (0-10%)
- Clinical Support (0-10%)
Essential Skills/Experience
- Life Sciences Degree or appropriate professional qualifications
- Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company
- Post-Brexit UK Regulatory experience
- Business Relationship Management and ability to navigate and coordinate cross-functional interactions
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Demonstrable negotiation skills
- Ability to make optimal use of IT systems
- Use of external regulatory environment and scientific knowledge skills to build a productive, positive and trustworthy relationship with local health authorities to drive meaningful interactions to the benefit of patients
- Lifecycle maintenance of the licenses, including different types of submissions including but not limited to CMC, Labelling, etc.
- Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines
- Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies
- Application of the knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities
- Application of Drug Development Knowledge
- Audit and Inspection Knowledge
Desirable Skills/Experience
- Therapy Area Expertise in Cardiovascular, Renal & Metabolism (CVRM)
- Experience with clinical trial applications (CTA)
- Experience in creating and delivering regulatory strategies for Marketing Authorization Applications and New Indications
- Experience working in Veeva systems
- Management of reaction to change & remaining effective in new work situations & times of uncertainty; Assessment of, planning for & managing the impact on stakeholders arising from changes & applying change management techniques to appropriately engage stakeholders
- A robust understanding of the disease and therapeutic area including the regulatory and health technology assessment environment in the major markets, competitor landscape, and predictable barriers/obstacles in development
At AstraZeneca, we change the practice of medicine by generating compelling medical evidence that helps physicians better treat patients at every point in their journey. Our cross-functional teams work seamlessly together, leveraging diverse skills to advance our pipeline and redefine cancer treatment. We foster a culture of openness, transparency, ambition, and drive. Here, you will find a supportive environment where you can grow your career while making a significant impact on patients' lives.
Ready to make a difference? Apply now!
Date Posted
11-Dec-2025
Closing Date
08-Jan-2026
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.
Regulatory Affairs Manager employer: AstraZeneca
Contact Detail:
AstraZeneca Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks and recent trends. Be ready to discuss how your experience aligns with the role of a Regulatory Affairs Manager, especially in managing complex submissions.
✨Tip Number 3
Showcase your project management skills! Be prepared to share examples of how you've successfully led projects in the past, particularly those that involved cross-functional teams and navigating regulatory challenges.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining our team at StudySmarter.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Know Your Stuff: Make sure you understand the regulatory framework and the specific requirements for the role. Highlight your relevant experience in regulatory affairs and project management to show us you're the right fit.
Tailor Your Application: Don’t just send a generic CV and cover letter. Customise your application to reflect the skills and experiences that align with the job description. We want to see how you can contribute to our team!
Showcase Your Achievements: When detailing your past roles, focus on your achievements rather than just responsibilities. Use metrics or examples to illustrate how you've successfully managed regulatory deliverables or led teams.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at AstraZeneca
✨Know Your Regulatory Stuff
Make sure you brush up on the regulatory framework relevant to the role. Understand the nuances of submission strategies for both small and large molecules, as well as regional trends. This will show that you're not just familiar with the basics but are ready to dive deep into the specifics.
✨Showcase Your Project Management Skills
Be prepared to discuss your project management experience in detail. Highlight specific examples where you've led multi-disciplinary teams or managed complex regulatory deliverables. Use the STAR method (Situation, Task, Action, Result) to structure your answers effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle certain regulatory challenges or risks. Think about past experiences where you identified risks and proposed mitigations. Practising these scenarios can help you articulate your thought process clearly during the interview.
✨Emphasise Team Collaboration
Since the role involves working with cross-functional teams, be ready to discuss how you've collaborated with others in previous roles. Share examples of how you’ve contributed to team success and how you’ve shared knowledge within your team. This will demonstrate your ability to work flexibly and effectively with diverse groups.
