CMC Medical/Regulatory Writer

Only for registered members United States

1 month ago

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Job summary

We are looking for an experienced CMC Medical/Regulatory Writing Consultant to support high-impact regulatory submissions and quality documentation across multiple programs. This role focuses exclusively on Chemistry, Manufacturing & Controls (CMC) writing and offers flexible, remote part-time hours.

Responsibilities

  • Author and review CMC sections for global submissions (Module 3, IND/IMPD, BLA/NDA/MAA).
  • Develop core CMC content: manufacturing/process narratives, analytical & validation summaries, stability data, control strategy docs, comparability and post-approval updates.

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