What are the responsibilities and job description for the Regulatory CMC Writer position at Katalyst CRO?
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.
Hourly Wage Estimation for Regulatory CMC Writer in Hackensack, NJ
$53.00 to $66.00
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