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Pharmaceutical CMC Writer (04+Months Contract)

Remote, USA Full-time Posted 2025-07-27
    SUMMARY:
  • A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control.
    JOB DESCRIPTION:
  • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ 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 advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
  • Identify, communicate and escalate potential CMC regulatory issues, as needed
  • Help establish regulatory CMC submission processes and procedures.
  • Familiar with eCTD format submission files
  • Project management skill is plus
    KEY RESPONSIBILITIES:
  • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
  • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
  • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
  • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
  • Process Improvement: Help establish regulatory CMC submission processes and procedures.

QUALIFICATIONS:

Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field.

    Experience:
  • Prior experience in pharmaceutical or regulatory writing.
  • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

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