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Katalyst Healthcares & Life Sciences
Regulatory CMC WriterKatalyst Healthcares & Life Sciences • Hackensack, NJ, United States
Regulatory CMC Writer

Regulatory CMC Writer

Katalyst Healthcares & Life Sciences • Hackensack, NJ, United States
4 days ago
Job type
  • Full-time
Job description

CMC Writer / Project Manager

Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.

This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.

Key Responsibilities:

  • 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.

Experience:

  • Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
  • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.
  • Familiarity with global regulatory frameworks and eCTD submissions.
  • Excellent technical writing, communication, and organizational skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
  • Veeva Vault, Smartsheet are plus

Preferred Skills:

  • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.
  • Ability to interpret and apply regulatory guidelines effectively.
  • Strong project management and stakeholder communication skills

Education:

  • Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
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Regulatory CMC Writer • Hackensack, NJ, United States

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