CMC Regulatory Affairs Associate (M3 Authoring experience for Biological products )

Overview

Join Our Growing Team of CMC Regulatory Professionals! The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control assessments, and ensuring compliance with regulatory requirements across multiple regions. The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.

Responsibilities

• Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and clien...