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 submissionTranslate technical source documents (process development, analytical, characterization reports) into clear, compliant regulatory textDraft and organize tables, figures, and process flow diagramsEnsure scientific accuracy, consistency, and regulatory alignment across documentsFormat 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 groupsParticipate in review cycles and incorporate feedback into final deliverablesSupport document cleanup and harmonization across multiple inputsProvide structured deliverables suitable for regulatory agency reviewQualifications: BS Degree minimum; 10+ years of relevant industry experience in biologics drug substance manufacturingStrong experience authoring Module 3 (CMC) sections for BLA and MAA submissionsStrong experience translating technical data into formal written reports or regulatory documentationDemonstrated technical writing and authorship capabilitiesDemonstrated ability to create submission-ready content (tables, figures, formatted sections)Proficiency in MS Office and Visio or similar toolsStrong communication skills and ability to work cross-functionally