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 p.duvall@proclinical.com.
Apply Now:
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