Regulatory Writer – Regulatory QC/Editor

Job Description:

• Write and edit a wide range of regulatory documents
• Perform independent QC reviews of documents produced by the regulatory writing function
• Verify the accuracy and internal/external consistency of documents
• Define and confirm the scope of QC activities with document authors
• Review documents for adherence to applicable style guides
• Proofread and copyedit text to ensure clarity and accuracy
• Support preparation and inspection‑readiness of technical documents
• Communicate QC findings clearly and constructively to stakeholders
• Facilitate the efficient project management of individual document workflows
• Contribute to the continuous improvement of QC tools, checklists, and processes

Requirements:

• Bachelor’s degree and 5 plus years of relevant experience
• Working knowledge of the industry and content of key eCTD documents
• Understanding of drug development and regulatory submission processes
• Exceptional attention to detail with strong analytical and critical‑thinking skills
• Proven ability to manage multiple tasks and priorities in a deadline‑driven environment
• Experience working cross‑functionally in collaborative team environments
• Experience with electronic document management and publishing systems
• Experience with project and timeline management systems

Benefits:

• Health insurance
• Flexible work hours
• Paid time off