CMC Writer

Job Summary

A company is looking for a CMC Writer to focus on regulatory affairs within the oncology and biotechnology sectors.

Key Responsibilities

• Manage Module 3 deliverables for US and EU filings, including new sections and updates
• Lead the writing process for NDA and MAA submissions, along with follow-on variations and supplements
• Coordinate with global experts and contract manufacturing organizations to gather necessary data

Required Qualifications

• Extensive experience in CMC medical writing for small or large molecules
• Proven leadership in NDA and MAA submissions
• Ability to work independently and manage multiple projects simultaneously