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Senior CMC Regulatory Technical Writer

posted by: spj_bot

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

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IT Business Systems Manager - Quality Systems

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States.

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile/waterfall environment, driving scalable and compliant technology solutions.

Accountabilities:

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