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About the role

Provide cross-functional scientific documentation support to ensure accuracy, completeness, and traceability. Work within Regulatory Affairs and Quality Assurance to support clinical, nonclinical, and CMC teams.
Key Responsibilities: Perform QC checks on scientific and regulated documents using established procedures and checklists. Manage document repositories, filing structures, metadata, and workflows in systems like SharePoint and Veeva. Prepare and retrieve document packages for regulatory submissions, audits, inspections, and due diligence.
Qualifications: Bachelor's degree in life sciences, biomedical sciences, chemistry, pharmacology, or related discipline. Experience with scientific document QC, regulated documentation, or document management is preferred. Strong attention to detail, analytical ability, and proficiency with Microsoft Word, Excel, and PowerPoint. Fully remote position for US-based candidates. Reports to VP, Regulatory Affairs and Quality Assurance and collaborates with Regulatory, QA, Clinical, Nonclinical, and CMC teams. Alterity Therapeutics Alterity Therapeutics is a late-stage clinical biotechnology company focused on developing disease-modifying treatments for rare and debilitating neurodegenerative disorders. They operate with a cross-functional team that prioritizes regulatory and quality excellence to support clinical development.

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JOB OVERVIEW

Experience level

Senior

Location

Denver, CO

Occupation

Regulatory Affairs Specialists

Industry

Other Scientific and Technical Consulting Services

Posted

yesterday

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