Job Description
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 document...
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 document...
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