CMC Regulatory Project Manager & Writer

Katalyst CRO; Paramus (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced CMC Writer/Project Manager to support regulatory submissions and deliver high-quality documentation for global health authorities. The role combines technical writing with project management to drive CMC deliverables across drug development programs.

Responsibilities include authoring and reviewing CTD/eCTD sections, managing timelines, coordinating AR/DSUR docs, ensuring FDA/EMA/ICH alignment, and collaborating with cross-functional teams to mitigate

Qualifications

• Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
• Strong knowledge of manufacturing processes, analytical methods, specs, and validation.
• Familiar with global regulatory frameworks and eCTD submissions.
• Excellent technical writing, communication, and organizational skills.

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, aligning with project goals.
• Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory questions.
• Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
• Collaborate with cross-functional teams to gather accurate technical information.
• Identify regulatory risks and propose mitigation strategies.
• Support process improvement initiatives for CMC submission workflows.

Skills

Technical writing

Project management

Regulatory writing

GxP compliance

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Advanced degree in related field

Tools

Veeva Vault

Smartsheet

Job description

Katalyst CRO is seeking an experienced CMC Writer/Project Manager to support regulatory submissions and deliver high-quality documentation for global health authorities. The role combines technical writing with project management to drive CMC deliverables across drug development programs.

Responsibilities include authoring and reviewing CTD/eCTD sections, managing timelines, coordinating AR/DSUR docs, ensuring FDA/EMA/ICH alignment, and collaborating with cross-functional teams to mitigate