CMC Writer

Job Title : CMC Writer

Job Location : Paramus, NJ

Job Type : Contract

Job Description :

Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD / eCTD format.

Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.

Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.

Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.

Collaborate with cross-functional teams to gather accurate technical information.

Identify and communicate potential regulatory risks; propose mitigation strategies.

Support process improvement initiatives for CMC submission workflows.