Senior Regulatory Affairs Specialist - EU- Remote

Worldwide Clinical Trials; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global CRO is seeking a Regulatory Affairs expert to navigate complex regulatory landscapes and support clinical trials. The role involves managing regulatory submissions, mentoring junior staff, and ensuring compliance with evolving regulations. Ideal candidates will have a degree in a related science and experience in clinical research within a CRO.

Qualifications

• Minimum of three years of experience in clinical research, site activation, or regulatory functions.
• Good knowledge of ICH GCP and country regulations.

Responsibilities

• Serve as a subject matter expert for regulatory submissions and site activation.
• Plan and track documents for regulatory submissions.

Skills

Organizational Skills

Management Skills

Proactive Problem Solving

Team-oriented Work Style

Education

Degree in a related science

Job description

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, a global team of over 3,500+ experts, bright thinkers, dreamers, and doers. 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 share this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and their caregivers. From our accessible leaders to our supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize a diverse and inclusive environment that promotes 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 navigates 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 supports the development and approval of innovative medical products, aids business development, and provides strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep stakeholders informed throughout the submission process.

What you will do

• Serve as a subject matter expert and local point of contact for activities supporting regulatory submissions, site activation, and maintenance for awarded projects.
• Plan, initiate, and track documents required for regulatory submissions, collect essential documents, review, and provide country/site/EC requirements to support site activation goals. Communicate status, risks, and actions related to start-up activities and maintenance when applicable.

What you will bring to the role

• Strong organizational and management skills, including planning, strategizing, managing, monitoring, scheduling, and critiquing.
• Self-motivated to learn about current regulatory processes and intelligence.
• Proactive in identifying potential issues and anticipating solutions.
• Thorough understanding of country-level cultural norms and local healthcare systems; ability to develop relationships with local investigators and site personnel.
• Ability to adapt to changing environments, prioritize, and balance detailed and strategic activities while maintaining timelines and quality.
• Team-oriented work style; seeks and provides guidance to others.

Your experience

• Degree in a related science such as medical, biological, physical, health, pharmacy, or similar.
• Minimum of three years of experience in clinical research, site activation, or regulatory functions within a CRO.
• Experience with the regulatory process in the UK and/or under EU-CTR (Poland, Denmark).
• Good knowledge of ICH GCP, clinical research guidance, and country regulations.
• Multilingualism preferred; fluent in the local language and proficient in English.

We love knowing that our work helps someone have a better life.

To view other roles, visit our careers page at Discover a world of difference at Worldwide! For more information, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer committed to fostering an inclusive environment that encourages collaboration and creativity. We value diversity and are dedicated to providing equal employment opportunities regardless of race, color, ethnicity, religion, gender, sexual orientation, age, disability, or other protected classes.