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- Tasks: Lead regulatory strategy and ensure compliance for oncology products in the UK.
- Company: Join a global pharmaceutical leader committed to innovation and inclusivity.
- Benefits: Competitive salary, inclusive environment, and opportunities for professional growth.
- Other info: We value diversity and provide support for all candidates.
- Why this job: Make a real impact in oncology while leading dynamic projects and teams.
- Qualifications: Life Sciences degree and significant regulatory experience in the pharmaceutical industry.
The predicted salary is between 60000 - 80000 £ per year.
The Regulatory Affairs Therapy Lead will drive strategy and regulatory processes for products within defined therapy areas, deliver and maintain competitive licences for the UK, drive regulatory strategy for new initiatives, ensure regulatory compliance for product and project responsibilities, lead projects and line‑manage teams, and provide timely delivery of clinical trial approvals while maintaining high regulatory compliance standards in the UK. The role also includes supporting the development of investigational and in‑licensed/co‑development products through contributions to MC3 projects, study feasibility questionnaires, scientific advice meetings, and other activities to ensure full compliance with GRP requirements in line with the local QMS SOP and all other AZ policies and standards.
Essential Skills / Experience
- Life Sciences Degree or appropriate professional qualifications.
- Significant experience within a Regulatory Affairs organisation at a UK‑based global pharmaceutical company.
- Line management experience or experience leading project teams.
- Operational regulatory experience in the pharmaceutical industry, including in a commercially aware role.
- Demonstrable negotiation skills and leadership capabilities.
- Strong working knowledge of MHRA requirements, ideally with experience post‑Brexit.
Desirable Skills / Experience
- Post‑graduate qualification.
- Therapy area expertise in one of the following: Respiratory, Cardiovascular, Diabetes, Renal, Oncology, injectable biologics, inhaled medicines, medical devices, vaccines.
- Experience in creating and delivering regulatory strategies for orphan drug applications, paediatric indications, new MAAs and new indications.
- Experience with clinical trial submissions.
We are committed to building an inclusive and equitable environment. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Regulatory Affairs Therapy Area Lead - Oncology employer: AstraZeneca
Contact Detail:
AstraZeneca Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Therapy Area Lead - Oncology
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those with experience in oncology. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MHRA requirements and recent changes post-Brexit. We want you to showcase your expertise and demonstrate how you can drive regulatory strategy effectively.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It shows professionalism and keeps you on their radar.
✨Tip Number 4
Apply through our website for the best chance at landing that dream job! We’re always looking for passionate candidates who are ready to make an impact in regulatory affairs, so don’t hesitate to put yourself out there.
We think you need these skills to ace Regulatory Affairs Therapy Area Lead - Oncology
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Therapy Area Lead role. Highlight your relevant experience in regulatory processes, especially in oncology or similar therapy areas. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can drive our strategy. Be sure to mention any specific experiences that relate to MHRA requirements or post-Brexit regulations.
Showcase Your Leadership Skills: Since this role involves line management and leading project teams, make sure to highlight your leadership experiences. We love to see examples of how you've successfully managed teams or projects in the past!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at AstraZeneca
✨Know Your Regulatory Stuff
Make sure you brush up on the latest MHRA requirements and any changes post-Brexit. Being able to discuss these in detail will show that you're not just familiar with the regulations but also understand their implications for the role.
✨Showcase Your Leadership Skills
Since the role involves line management and leading project teams, be ready to share specific examples of how you've successfully led teams or projects in the past. Highlight your negotiation skills and how you've navigated challenges in a regulatory context.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about your past experiences and be prepared to explain your thought process and decision-making in those situations.
✨Align with Their Values
Familiarise yourself with the company's commitment to equitable employment and inclusivity. Be ready to discuss how you can contribute to this environment and why it matters to you personally.