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CMC Regulatory Affairs Specialist
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- Job title: CMC Regulatory Technical Writer II
- Hybrid - onsite Tuesday & Thursday - This can change at any time.
- Expert in Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus
- The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
- The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
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