Job Description

Technical Writer – Regulatory CMC Documentation

Location: New Brunswick, NJ / Princeton Pike, NJ

Schedule: Monday – Friday, Normal Business Hours

Work Model: 50% Onsite Required

Duration: 12 Months (High possibility of extension based on performance and business needs)

Position Summary

We are seeking a Technical Writer with experience in Regulatory CMC documentation within the pharmaceutical or biotechnology industry. This role will support regulatory submission activities for a late-stage cell therapy program and will work closely with cross-functional teams including Regulatory Affairs, Process Development, Analytical Development, Quality, and Technical Operations.

The ideal candidate will have hands-on experience supporting eCTD regulatory submissions, strong technical writing capabilities, and the ability to manage multiple timelines in a fast-paced environment.

Responsibilities

• Author, edit, and review Regulatory CMC documentation for regulatory submissions
• Support preparation of dossiers and submission-related documents aligned with regulatory strategy
• Coordinate with SMEs to gather source documentation and ensure timely content delivery
• Assist with eCTD submission preparation and document management activities
• Review technical content for accuracy, consistency, formatting, and compliance readiness
• Track submission timelines, document status, and project milestones
• Facilitate comment resolution and support data verification activities
• Collaborate cross-functionally with Regulatory Affairs, Quality, Technical Operations, and Development teams
• Maintain organized documentation and ensure adherence to submission deadlines

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, Life Sciences, or related discipline
• Minimum 2+ years of Technical Writing experience focused on Regulatory CMC documentation within pharma or biotech industry
• Familiarity with eCTD structure and regulatory submission processes
• Strong written and verbal communication skills
• Excellent attention to detail, planning, organizational, and coordination skills
• Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and SharePoint
• Ability to work independently and manage multiple priorities in a deadline-driven environment

Preferred Qualifications

• Experience supporting IND/BLA submissions
• Cell therapy or biologics experience preferred
• Experience working with cross-functional regulatory and scientific teams
• Familiarity with compliance-ready document formatting and publishing standards

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