CMC Writer, CMC Writing

The role involves supporting global regulatory submissions by authoring and reviewing high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for biologics and other products. You will translate complex scientific data into clear regulatory narratives, coordinate document reviews with cross-functional teams, and ensure timely delivery of submission materials. Responsibilities include preparing Module 3 CTD sections, responding to health authority questions, verifying data accuracy, maintaining documentation traceability, and supporting lifecycle updates. You will leverage AI and digital tools to enhance writing quality and efficiency, while adhering to quality systems and regulatory standards. The ideal candidate holds a master’s degree in science or a related field, with at least four years of experience in CMC or biotech/pharma manufacturing. Strong writing skills, knowledge of GxP and CTD structure, experience with global regulatory filings, and stakeholder collaboration are essential. Proactive planning, attention to detail, and familiarity with digital tools for scientific writing are also required. This position offers a competitive salary range and benefits supporting well-being and professional growth.