Regulatory CMC WriterKatalyst HealthCares & Life Sciences • Hackensack, NJ
Regulatory CMC Writer
Katalyst HealthCares & Life Sciences • Hackensack, NJ
30+ days ago
Job type
- Full-time
Job 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, and Controls (CMC) deliverables across drug development programs.
- 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.
- Minimum 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 , PowerPoint).
- Veeva Vault, Smartsheet are plus
- 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
- Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
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Regulatory CMC Writer • Hackensack, NJ
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