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- Tasks: Manage regulatory submissions and support marketing applications in the oncology sector.
- Company: Join a leading global biopharmaceutical company making strides in cancer treatment.
- Benefits: Enjoy a fully remote role with potential for contract extension and flexible working.
- Why this job: Be part of a dynamic team impacting patient lives through innovative oncology solutions.
- Qualifications: Experience in Regulatory Affairs and strong knowledge of EU regulations required.
- Other info: This is a 12-month contract with opportunities for professional growth.
The predicted salary is between 43200 - 72000 £ per year.
This global biopharmaceutical company is looking for an experienced Regulatory Affairs professional to join them on a contract basis. A 12-month, remote contract job with scope for extension.
As Regulatory Affairs Manager, you will work closely with the EU Regulatory Lead within the oncology team, managing the operational and procedural aspects and providing support for new Marketing Authorisation Applications’ preparation and filings as well as Life Cycle Management for the European Centralised Procedures and clinical trial applications.
You will plan and track activities related to regulatory submissions in the EU, communicating regulatory submission dates, regulatory status, nature of changes, and tracking and informing of minor/significant product information changes to all relevant parties.
What you’ll need to succeed:
- Previous experience working in Regulatory Affairs and a strong working knowledge of EU regulations.
- Experience working directly with EMEA on different types of submissions.
- Clinical experience.
- Strong EU CTR knowledge is essential.
Regulatory Affairs Manager EU Remote employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager EU Remote
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with EU regulations and oncology. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 2
Familiarise yourself with the specific requirements for Marketing Authorisation Applications and clinical trial applications in the EU. This knowledge will not only boost your confidence but also demonstrate your commitment to the role during discussions.
✨Tip Number 3
Stay updated on recent changes in EU regulations and guidelines related to oncology. Being well-informed will help you engage in meaningful conversations with the hiring team and show that you are proactive in your professional development.
✨Tip Number 4
Prepare to discuss your previous experiences with EMEA submissions in detail. Highlight specific challenges you faced and how you overcame them, as this will showcase your problem-solving skills and expertise in regulatory affairs.
We think you need these skills to ace Regulatory Affairs Manager EU Remote
Some tips for your application 🫡
Understand the Role: Familiarise yourself with the specific responsibilities of a Regulatory Affairs Manager in the oncology sector. Highlight your relevant experience and knowledge of EU regulations in your application.
Tailor Your CV: Ensure your CV reflects your previous experience in Regulatory Affairs, particularly with EMEA submissions and clinical trials. Use keywords from the job description to make your application stand out.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for oncology and regulatory affairs. Mention specific examples of your past work that align with the requirements of the role, especially your experience with Marketing Authorisation Applications.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A polished application demonstrates professionalism and attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Hays
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of EU regulations and your experience with EMEA submissions. Be prepared to discuss specific examples from your past roles that demonstrate your expertise in regulatory affairs, particularly in oncology.
✨Prepare for Technical Questions
Expect questions related to the operational and procedural aspects of regulatory submissions. Brush up on your knowledge of Marketing Authorisation Applications and Life Cycle Management processes, as well as any recent changes in regulations that may impact the role.
✨Demonstrate Communication Skills
As the role involves tracking and communicating regulatory submission statuses, be ready to showcase your communication skills. Provide examples of how you've effectively communicated complex regulatory information to various stakeholders in your previous positions.
✨Discuss Your Clinical Experience
Since clinical experience is essential for this role, prepare to discuss your background in clinical trials. Highlight any specific projects you've worked on, your role in those projects, and how they relate to regulatory submissions in the EU.
