Regulatory Documentation Scientist - #2086895

Role: Regulatory Documentation Scientist

Location: Remote or Hybrid

Hours: Full-time

Pay: £55.96 - £67.16 per hour PAYE basic excluding holiday pay or £75 - £90 per hour LTD/UMB

Contract: 12-month Contract (Outside IR35)

An excellent opportunity has arisen for a Regulatory Documentation Scientist to join one of our longstanding global pharmaceutical clients within their Pharmaceutical Research and Early Development function.

This is a 12-month contract, outside IR35, supporting global regulatory submissions and scientific documentation activities. The successful candidate will work closely with scientific and regulatory stakeholders to prepare high-quality nonclinical documentation for health authority submissions across the drug development lifecycle.

Benefits:

• 12-month contract outside IR35
• Remote or hybrid working options available
• Opportunity to work within a leading global pharmaceutical organisation
• Exposure to early and late-stage drug development programmes
• Collaborative and highly scientific working environment

The Requirements:

• Degree in Life Sciences or a related scientific discipline
• Several years of experience in scientific writing within a nonclinical, medical writing or regulatory writing environment
• Strong experience supporting regulatory submissions and scientific documentation
• Understanding of nonclinical development and regulatory requirements
• Experience supporting IND, CTA, NDA, MAA, BLA or similar regulatory submissions
• Excellent written communication and document editing skills
• Strong stakeholder management and collaboration skills
• Experience using scientific writing and document management software
• Proactive approach with strong attention to detail and quality standards

The Role:

• Manage the preparation, review and submission of nonclinical regulatory documents
• Support documentation for early development and marketing applications
• Collaborate with regulatory and scientific teams to ensure accurate and compliant submissions
• Work closely with Nonclinical Project Leaders and Scientists to prepare study reports and submission documents
• Ensure documentation meets internal standards and regulatory requirements
• Support the development and maintenance of scientific writing processes, tools and guidelines
• Contribute to regulatory initiatives, process improvements and technology projects
• Ensure all documentation is clear, accurate, consistent and submission-ready

This role would suit an experienced Nonclinical Scientific Writer, Medical Writer or Regulatory Writer with a strong background in scientific documentation and regulatory submissions within the pharmaceutical industry.

If you're keen to join an exceptional team who can offer scientific collaboration, global regulatory exposure and the opportunity to contribute to the development of innovative medicines, then please apply to this Regulatory Documentation Scientist role below or call Chloe McCausland on between 8:30am - 5:00pm.