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For Companies At a Glance
- Tasks: Coordinate regulatory submissions and ensure compliance for clinical trials.
- Company: Join a global CRO dedicated to innovative healthcare solutions.
- Benefits: Enjoy remote work flexibility and a supportive, inclusive culture.
- Why this job: Make a real impact in healthcare while growing your career with accessible leadership.
- Qualifications: Degree in health/science and 3 years' experience in regulatory affairs required.
- Other info: This is a mid-senior level, full-time position based remotely within the EU.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Senior Regulatory Affairs Specialist - EU- Home Based role at Worldwide Clinical Trials.
About Us
We’re a global, midsize CRO committed to innovation and excellence in developing treatments for persistent diseases. Our team of over 3,500 experts worldwide is dedicated to improving lives and making a difference in healthcare.
Why Join Us
We foster a diverse, inclusive environment that encourages collaboration and creativity. Our leadership is accessible, and we support professional growth, enabling our employees to thrive and succeed.
Department Overview
The Regulatory Affairs team navigates complex regulatory landscapes, manages submissions, ensures compliance across regions, and provides strategic guidance to support clinical trials and product development.
Key Responsibilities
- Coordinate and submit regulatory documents timely, liaising with colleagues and external partners.
- Review and ensure compliance of documentation such as labels, patient info sheets, and consent forms.
- Maintain regulatory databases and stay updated on legislative changes.
- Advise on regulatory strategies and interpret new legislation.
- Foster relationships with internal teams and external agencies to expedite approvals.
Qualifications & Skills
- Degree in a health or science-related field.
- At least 3 years’ experience in clinical research or regulatory affairs within a CRO.
- Knowledge of UK and EU-CTR regulatory processes.
- Strong organizational, communication, and multitasking skills.
- Proficiency in MS Office; multilingual skills are a plus.
Additional Information
Position: Mid-Senior level, Full-time, Remote within EU. We are an equal opportunity employer committed to diversity and inclusion.
Senior Regulatory Affairs Specialist - EU- Home Based employer: Worldwide Clinical Trials
Contact Detail:
Worldwide Clinical Trials Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist - EU- Home Based
✨Tip Number 1
Familiarise yourself with the latest EU regulatory guidelines and frameworks. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly changing field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who work within CROs. Engaging with industry peers can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've navigated regulatory challenges in past roles. Highlighting your problem-solving skills and experience will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to collaborate effectively with cross-functional teams. Since the role involves liaising with various stakeholders, demonstrating your teamwork skills will be crucial during the interview process.
We think you need these skills to ace Senior Regulatory Affairs Specialist - EU- Home Based
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Regulatory Affairs Specialist position. Tailor your application to highlight relevant experience in regulatory affairs and clinical research.
Craft a Tailored CV: Your CV should reflect your experience in regulatory affairs, particularly within a CRO environment. Emphasise your knowledge of UK and EU-CTR regulatory processes, and include specific examples of your past work that align with the job description.
Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your skills can contribute to Worldwide Clinical Trials. Mention your ability to coordinate submissions and maintain compliance, as well as your strong organisational and communication skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects attention to detail, which is crucial in regulatory affairs. Consider asking a friend or colleague to review it as well.
How to prepare for a job interview at Worldwide Clinical Trials
✨Know Your Regulatory Landscape
Familiarise yourself with the latest UK and EU-CTR regulatory processes. Be prepared to discuss recent changes in legislation and how they might impact clinical trials, as this will demonstrate your expertise and commitment to the field.
✨Showcase Your Experience
Highlight your previous experience in regulatory affairs or clinical research, especially within a CRO. Use specific examples to illustrate how you've successfully managed submissions or ensured compliance, as this will help you stand out.
✨Emphasise Communication Skills
Since the role involves liaising with various teams and external partners, be ready to discuss how you effectively communicate complex regulatory information. Share examples of how you've built relationships to expedite approvals.
✨Demonstrate Organisational Skills
Prepare to talk about your organisational strategies, especially when managing multiple regulatory documents and deadlines. Discuss tools or methods you use to stay organised, as this is crucial for success in the role.
