Regulatory CMC Technical Writer

Overview:

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 scientific accuracy, consistency, and regulatory alignment across documents
• Format content for regulatory submission standards (CTD structure, cross-referencing, formatting best practices)
• Collaborate closely with SMEs across Process Development (upstream/downstream), Analytical teams, Quality & CMC groups
• Participate in review cycles and incorporate feedback into final deliverables
• Support document cleanup and harmonization across multiple inputs
• Provide structured deliverables suitable for regulatory agency review

Qualifications:

• BS Degree minimum; 10+ years of relevant industry experience in biologics drug substance manufacturing
• Strong experience authoring Module 3 (CMC) sections for BLA and MAA submissions
• Strong experience translating technical data into formal written reports or regulatory documentation
• Demonstrated technical writing and authorship capabilities
• Demonstrated ability to create submission-ready content (tables, figures, formatted sections)
• Proficiency in MS Office and Visio or similar tools
• Strong communication skills and ability to work cross-functionally