Regulatory CMC Technical Writer

Our client is seeking an experienced Regulatory CMC Technical Writer to support the preparation of Module 3 (CMC) sections for a biologics regulatory submission. The ideal candidate will combine strong technical expertise in biologics manufacturing with regulatory writing capabilities, translating complex process development and characterization data into clear, submission‑ready documentation.

This is a 4-6 month assignment with strong likelihood of extension based on performance. There is a strong preference for local consultants who can work 2-3 days/week in Hampton, NJ.

Responsibilities :

• Author and support development of Module 3 (CMC) content for a biologics submission
• Translate technical source documents (process development, analytical, characterization reports) into clear, compliant regulatory text
• Draft and organize tables, figures, and process flow diagrams
• Ensure scienti...

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