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- Tasks: Lead regulatory submissions and strategy for biotech products in the EU.
- Company: Join a renowned biotech company with a strong reputation in the industry.
- Benefits: Enjoy remote work flexibility with monthly office visits.
- Why this job: Make an impact in global regulatory affairs while collaborating with diverse teams.
- Qualifications: Experience in marketing applications and clinical trials is essential.
- Other info: This is a 12-month contract with potential for extension.
The predicted salary is between 43200 - 72000 £ per year.
This well-known biotech is looking for an experienced Regulatory Affairs Manager to join their established EU Regulatory Affairs team. This is a 12-month contract with scope for extension. It is a remote contract with the need to go into the office once per month.
As a Global Regulatory Affairs Manager, you will support the creation of strategy and execution plans, and manage regulatory submissions (clinical trial and marketing applications) for products within the portfolio, ensuring compliance with global filing plans and local regulatory requirements. You will take the lead in advising the Global Regulatory team on regional considerations in developing strategy, and ensure regional needs are well-defined and implemented in collaboration with relevant regional stakeholders.
What you'll need to succeed:
- Prior experience in the region of MAs, CTAs, post-approval changes, amendments, extensions, and renewals is required.
- A strong working knowledge of EU CTR would be an advantage.
What you'll get in return:
- Remote working opportunity.
Senior Regulatory Affairs Manager EU employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager EU
✨Tip Number 1
Network with professionals in the biotech and regulatory affairs sectors. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends in EU regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the EU, particularly the Clinical Trials Regulation (CTR). This knowledge will help you stand out during discussions with our team.
✨Tip Number 3
Prepare to discuss your previous experiences with marketing applications and clinical trial submissions. Be ready to share specific examples of how you've navigated regulatory challenges in the past.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams. Highlight any past experiences where you successfully worked with stakeholders to align regulatory strategies with business goals.
We think you need these skills to ace Senior Regulatory Affairs Manager EU
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior Regulatory Affairs Manager. Familiarise yourself with regulatory submissions, compliance requirements, and the specific needs of the EU market.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, particularly focusing on your work with marketing applications and clinical trials. Use specific examples that demonstrate your knowledge of EU regulations and your ability to manage submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the biotech industry. Mention your previous successes in similar roles and how they align with the company's goals.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at TN United Kingdom
✨Know Your Regulatory Landscape
Familiarise yourself with the latest EU regulations and guidelines related to clinical trials and marketing applications. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and commitment to the field.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience with marketing authorisations, clinical trial applications, and post-approval changes. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Understand the Company’s Portfolio
Research the biotech company’s products and their regulatory history. Being knowledgeable about their portfolio will allow you to tailor your answers and show how your skills can directly benefit their operations.
✨Emphasise Collaboration Skills
As the role involves working with various regional stakeholders, be prepared to discuss your experience in cross-functional teams. Highlight instances where you successfully collaborated with others to achieve regulatory goals.
