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CMC Writer needs 4+ years’ experience
CMC Writer requires:
o Prior experience in pharmaceutical or regulatory writing.
o CMC (Chemistry, Manufacturing, and Controls) Writer experience.
o Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field
o CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA, IND, BLA, NDA, eCTD, Project Management, Pharmaceutical
o Familiar with eCTD format submission files
o Project management skill is plus

CMC Writer duties:
o Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
o Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
o Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
o Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
o Process Improvement: Help establish regulatory CMC submission processes and procedures.

Reference : CMC Writer Pays $49/hr Paramus, NJ jobs

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Published at 25-07-2025
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