Regulatory Documentation Scientist

Proclinical; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading regulatory consultancy firm in the United Kingdom is seeking a Regulatory Documentation Scientist to manage the preparation and submission of nonclinical regulatory documents. You will ensure high-quality documentation for regulatory submissions collaborating with cross-functional teams. This position offers flexibility with remote or hybrid work options, making it ideal for balancing productivity and collaboration. The candidate should possess a relevant degree and experience in scientific writing, along with strong collaboration skills.

Qualifications

• Experience in scientific writing and editing within a nonclinical regulatory domain.
• Proficiency with writing technologies and tools.
• Strong skills in collaboration and effective communication.

Responsibilities

• Manage the preparation and submission of nonclinical summary documents.
• Collaborate with teams for comprehensive nonclinical dossiers.
• Draft regulatory submission documents and study reports.
• Develop processes and guidelines for document production.
• Represent the nonclinical team in global regulatory initiatives.

Skills

Scientific writing

Collaboration

Communication skills

Problem-solving

Education

University degree in a life science discipline

Tools

Writing and editing software

Job description

Crafting compliant, high-impact regulatory documents that drive global drug development forward.

Proclinical is seeking a Regulatory Documentation Scientist to support the preparation and submission of nonclinical regulatory documents. This role focuses on ensuring high-quality, compliant documentation for regulatory submissions, including INDs, CTAs, NDAs, MAAs, and BLAs. You will collaborate with cross‑functional teams to deliver accurate and impactful scientific content.

This position offers flexibility with remote or hybrid work options, empowering you to balance productivity and collaboration.

Responsibilities

• Manage the preparation, review, and submission of nonclinical summary documents for early development and marketing applications.
• Collaborate with regulatory and scientific teams to ensure comprehensive and accurate nonclinical dossiers are submitted to health authorities.
• Work closely with Nonclinical Project Leaders and Scientists to draft regulatory submission documents, study reports, and other research-related materials.
• Develop and maintain processes, tools, and guidelines to ensure high-quality document production.
• Represent the nonclinical team in global regulatory initiatives and projects focused on process and technology improvements.

Key Skills and Requirements

• A university degree in a life science discipline.
• Experience in scientific writing and editing within a nonclinical regulatory domain.
• Proficiency in writing and editing software, with an interest in exploring new tools and technologies.
• Strong collaboration and communication skills, with the ability to build trust and work effectively with diverse stakeholders.
• A commitment to producing high-quality, customer-focused documentation.
• Proactive problem-solving skills and a sense of ownership over your work.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at [e-mail].

Apply Now

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.