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Job descriptions of CMC Writer
19 Oct 2023

Job descriptions of CMC Writer

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CMC Writer’s primary responsibility is to ensures smooth progress of regulatory CMC submissions to health authorities. They involves in regulatory CMC submissions – applying intelligence and developing regulatory strategy. Here are the sample job description of the CMC Writer.

Key Responsibilities of CMC Writer

  • Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Support the coordination and preparation of timely CTD file for submissions.
  • Authoring and review of CMC submission components and documentation in CTD to support ¬†regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
  • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
  • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions
  • Assess and communicate potential regulatory risks and propose mitigation strategies
  • Understands, interprets and advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of applications.
  • Identify, communicate and escalate potential CMC regulatory issues, as needed
  • Help establish regulatory CMC submission processes and procedures.

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