Regulatory Writing Submission Graduate in City of London

Job description

Location: White City, London

Pay Rate: £31,050

12 Month Fixed Term Contract

Hybrid Working Scheme - 2/3 days on site per week

About the Role

We’re looking for a detail-oriented and scientifically driven Regulatory Writing Submissions Graduate to join our clients Regulatory Writing & Submissions (RWS) team. In this role, you’ll contribute to the creation of high-quality clinical and safety documentation that supports global drug development and regulatory submissions.

Key Responsibilities

• Draft and edit clinical and safety documents under guidance, including:
• Clinical Study Protocols (CSPs) and amendments
• Non-registration Clinical Study Reports (CSRs)
• Development Safety Update Reports (DSURs)
• Clinical Trial Registration Documents
• Represent RWS in Clinical Trial Teams (CTTs)
• Support planning of data analyses and presentation for CSRs
• Ensure documentation complies with internal standards and regulatory guidelines
• Liaise with publishing teams to ensure timely delivery of final documents
• Contribute to process improvements within RWS
• Maintain compliance with audits, SOPs, and training requirements

What Success Looks Like

• Timely delivery of high-quality documents that meet internal and external standards
• Completion of a meaningful volume of work annually, aligned with performance metrics

Qualifications & Experience

Education:

• Minimum: University degree in life sciences or equivalent
• Preferred: Advanced degree in life sciences or healthcare

Experience:

• Some experience in medical writing or relevant pharmaceutical industry roles
• Solid understanding of global regulatory processes and documentation
• Familiarity with biostatistics principles
• Strong problem-solving and project management skills
• Excellent written and verbal communication skills
• Ability to work in a matrixed, cross-cultural environment

Why Join Us?

This is a fantastic opportunity to grow your career in regulatory writing within a collaborative and globally connected team. You’ll be at the forefront of clinical documentation, helping bring innovative therapies to patients worldwide.

Extra information

Status

Open

Education Level

Secondary School

Location

City of London

Type of Contract

Part-time jobs

Published at

16-09-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English