At a Glance
- 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 in London employer: AstraZeneca
As a leading global pharmaceutical company, we pride ourselves on fostering a dynamic and inclusive work environment that empowers our employees to excel in their roles. Our commitment to employee growth is reflected in our comprehensive training programmes and opportunities for career advancement, particularly in the vibrant UK market where innovation thrives. Join us to be part of a team that not only drives regulatory excellence in oncology but also values collaboration, diversity, and the well-being of our workforce.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Therapy Area Lead - Oncology in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those with oncology expertise. 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 understanding of regulatory compliance and how it impacts product approvals.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss your experience in line management and leading project teams. We love candidates who can demonstrate their ability to drive strategy and deliver results.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re committed to building an inclusive environment, so we welcome all qualified candidates.
We think you need these skills to ace Regulatory Affairs Therapy Area Lead - Oncology in London
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 the job description.
Showcase Your Leadership Skills:Since this role involves line management and leading projects, make sure to highlight your leadership experience. Share examples of how you've successfully managed teams or projects in the past, particularly in a regulatory context.
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 shows you’re keen on joining our team 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 proactive about staying updated.
✨Showcase Your Leadership Skills
Since this 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.
✨Understand the Therapy Area
Dive deep into oncology and related therapy areas. Familiarise yourself with current trends, challenges, and innovations in the field. This knowledge will help you demonstrate your expertise and passion during the interview.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges or scenarios. Think through potential situations you might face in this role and prepare structured responses that showcase your problem-solving abilities and compliance focus.
