Senior Regulatory Affairs Specialist - EU- Home Based

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

Job summary

A leading global CRO is seeking a Senior Regulatory Affairs Specialist to join their team. This remote position requires a degree in a health or science-related field and at least 3 years of experience in regulatory affairs. The role involves coordinating regulatory submissions, ensuring compliance, and advising on regulatory strategies. Join a diverse and inclusive environment that supports professional growth and innovation.

Qualifications

• At least 3 years’ experience in clinical research or regulatory affairs within a CRO.
• Proficiency in MS Office; multilingual skills are a plus.

Responsibilities

• Coordinate and submit regulatory documents timely.
• Review and ensure compliance of documentation.
• 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.

Skills

Organizational skills

Communication skills

Multitasking skills

Knowledge of UK and EU-CTR regulatory processes

Education

Degree in a health or science-related field

Tools

MS Office

Job description

Senior Regulatory Affairs Specialist - EU- Home Based

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

1. Coordinate and submit regulatory documents timely, liaising with colleagues and external partners.
2. Review and ensure compliance of documentation such as labels, patient info sheets, and consent forms.
3. Maintain regulatory databases and stay updated on legislative changes.
4. Advise on regulatory strategies and interpret new legislation.
5. 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.