Sign upLog in
See more jobs

["Regulatory CMC Writer","Regulatory CMC Writer"]

Katalyst Healthcares and Life Sciences

  • Hackensack
  • 5 days ago

    Highlights

    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, andControls (CMC) deliverables across drug development programs.

    Numbers & Facts

    LocationHackensack

    Description

    • 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, andControls (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.

    Similar Jobs

    See more jobs