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- Tasks: Lead regulatory submissions and ensure compliance for clinical trials across Europe.
- Company: Join Worldwide Clinical Trials, a global CRO dedicated to innovative healthcare solutions.
- Benefits: Enjoy remote work flexibility, a supportive team culture, and opportunities for professional growth.
- Why this job: Make a real impact on patients' lives while working in a diverse and inclusive environment.
- Qualifications: Degree in a related science and three years of experience in clinical research or regulatory affairs.
- Other info: Multilingual candidates preferred; must understand UK/EU regulatory processes.
The predicted salary is between 30000 - 42000 ÂŁ per year.
Senior Regulatory Affairs Specialist – EU- Remote
Join to apply for the Senior Regulatory Affairs Specialist – EU- Remote role at Worldwide Clinical Trials
Senior Regulatory Affairs Specialist – EU- Remote
Join to apply for the Senior Regulatory Affairs Specialist – EU- Remote role at Worldwide Clinical Trials
Who We Are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
Who We Are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What The Regulatory Affairs Department Does At Worldwide
Regulatory Affairs is pivotal in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process
What You Will Do
- You will be a subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects.
- You will be responsible for planning, initiating, and tracking documents required for regulatory submissions, essential documents collection, review, and provision of country/site/EC requirements to support the achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.
What You Will Bring To The Role
- Strong organizational and management skills. Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
- Self-motivated learning about current regulatory processes and intelligence
- Proactive by identifying potential issues in the process and anticipating solutions
- Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
- Easily adjusts to a changing environment; ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality
- Team-oriented work style; seeks and gives guidance to others
Your Experience
- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO
- Candidates must have experience of the regulatory process in the UK/ and/or under EU-CTR (Poland, Denmark) to be considered for this role.
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
- Multilingualism preferred; fluent in local language; working knowledge of English
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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Senior Regulatory Affairs Specialist - EU- Remote 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- Remote
✨Tip Number 1
Familiarise yourself with the specific regulatory processes in the UK and EU, especially under the EU-CTR. This knowledge will not only help you understand the role better but also demonstrate your commitment to the position during discussions.
✨Tip Number 2
Network with professionals already working in regulatory affairs within CROs. Engaging with them on platforms like LinkedIn can provide insights into the company culture at Worldwide Clinical Trials and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory guidelines by following relevant industry publications and attending webinars. This proactive approach will showcase your dedication to continuous learning and adaptability.
✨Tip Number 4
Prepare to discuss your experience with site activation and regulatory submissions in detail. Be ready to share specific examples of challenges you've faced and how you overcame them, as this will highlight your problem-solving skills and expertise.
We think you need these skills to ace Senior Regulatory Affairs Specialist - EU- Remote
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Specialist position. Tailor your application to highlight your relevant experience in regulatory submissions and clinical research.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with the regulatory process in the UK and EU-CTR, as well as your knowledge of ICH GCP and local healthcare systems. Use specific examples to demonstrate your expertise.
Showcase Soft Skills: The job requires strong organisational and management skills. Make sure to mention your ability to adapt to changing environments, prioritise tasks, and work collaboratively within a team. Provide examples of how you've successfully navigated challenges in previous roles.
Craft a Compelling Cover Letter: Your cover letter should not only reiterate your qualifications but also convey your passion for improving lives through clinical trials. Discuss why you want to work at Worldwide Clinical Trials and how your values align with their mission.
How to prepare for a job interview at Worldwide Clinical Trials
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory processes and guidelines, especially those relevant to the UK and EU-CTR. Being able to discuss these in detail will demonstrate your expertise and readiness for the role.
✨Showcase Your Organisational Skills
Prepare examples that highlight your strong organisational and management skills. Discuss how you've successfully planned and tracked regulatory submissions in previous roles, as this is crucial for the position.
✨Demonstrate Proactivity
Be ready to share instances where you identified potential issues in regulatory processes and how you proactively addressed them. This shows your ability to anticipate challenges and find solutions.
✨Cultural Awareness and Relationship Building
Highlight your understanding of country-level cultural norms and local healthcare systems. Discuss how you've built relationships with local investigators and site personnel, as this is key for successful site activation.
