Regulatory CMC Writer

We are looking for an experienced CMC Technical Writer to join a growing biopharmaceutical organisation developing biologics and biosimilar products.

The role will focus on preparing, coordinating and reviewing high-quality CMC regulatory documentation , with particular emphasis on CTD Module 3 . You will work closely with CMC, Manufacturing, Quality, Analytical Development, Regulatory Affairs and Process Development teams to translate complex technical information into clear, accurate and submission-ready documentation.

Key Responsibilities

• Author and coordinate CTD Module 3 (CMC) documentation for biologic and/or biosimilar products.
• Prepare and update CMC sections covering drug substance, drug product, manufacturing processes, analytical methods, specifications, validation and stability .
• Translate complex CMC and scientific data into clear, regulatory-compliant documentation.
• Work closely with CMC, QA, QC, Manufacturing, Process Development and Regulatory Affairs stakeholders.
• Support preparation of regulatory submissions, amendments and responses to Health Authority questions.
• Review and edit technical documentation for accuracy, consistency and regulatory compliance.
• Manage input from multiple technical contributors and ensure documentation is delivered to agreed timelines.
• Support lifecycle management and updates to existing CMC documentation.

Requirements

• Proven experience as a CMC Technical Writer / CMC Writer / Regulatory CMC Writer within the pharmaceutical or biotechnology industry.
• Experience with biologics, biosimilars or other complex biological products .
• Good understanding of pharmaceutical development and CMC principles across Drug Substance and Drug Product .
• Experience working cross-functionally with CMC, Quality, Manufacturing, Analytical and Regulatory teams.
• Strong scientific writing, editing and document management skills.
• Ability to understand complex technical information and communicate it clearly within regulatory documentation.