Regulatory CMC Writer

Discover International; Berlin; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Discover International is seeking an experienced CMC Technical Writer to join a growing biopharmaceutical organisation developing biologics and biosimilar products. The role focuses on preparing, coordinating and reviewing high-quality CMC regulatory documentation, with emphasis on CTD Module 3, and translating complex data into submission-ready files.

You will collaborate with CMC, Manufacturing, Quality, Analytical Development, Regulatory Affairs and Process Development teams to deliver

Qualifikationen

• Experience as a CMC Technical Writer within the pharmaceutical or biotechnology industry.
• Biologics, biosimilars or other complex biological products familiarity.
• Solid understanding of Drug Substance and Drug Product CMC principles.
• Experience working cross-functionally with CMC, Quality, Manufacturing, Analytical and Regulatory teams.

Aufgaben

• 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 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.

Kenntnisse

Regulatory writing

Technical writing

Documentation management

Cross-functional collaboration

Jobbeschreibung

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.