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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.

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Sr. Director/Executive Director, Analytical Development

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 a Sr. Director/Executive Director, Analytical Development in the United States.

In this role, you will oversee the analytical development and commercial quality control functions for late-stage small molecule programs. You will play a key role in regulatory strategy and execution, ensuring robust analytical methods and high-quality data packages to support regulatory submissions. This position will collaborate cross-functionally with formulation, manufacturing, and quality teams, and interface closely with external partners. It is ideal for a scientific leader with deep technical expertise, a hands-on mindset, and a passion for impactful drug development. The environment is fast-paced, virtual, and mission-driven, requiring adaptability and a solutions-focused approach.

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