Regulatory Documentation Scientist

6 days ago

Hertfordshire, United Kingdom Proclinical Full time

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.

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