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 per week in Hampton, NJ.

• Author and support the 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 practice).
• Collaborate closely with SMEs across Process Development (upstream/downstream), Analytical teams, and 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.

• 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.