Regulatory CMC Manager | Chemiker/in

Job Summary

As a Regulatory CMC Manager at Novartis, you will lead global regulatory strategies for Chemistry, Manufacturing, and Controls (CMC), specifically focusing on innovative Cell & Gene Therapy projects. Your day-to-day responsibilities involve planning, authoring, and reviewing high-quality technical documentation for Health Authority submissions to support both new product launches and post-marketing activities. You will act as a key liaison, negotiating with Health Authorities and collaborating with cross-functional project teams to ensure regulatory compliance and technical congruency. This role is unique for its focus on cutting-edge modalities and the opportunity to manage the entire product lifecycle within a global pharmaceutical leader. Based in Schaftenau with hybrid work options, the position offers a competitive salary and the chance to influence risk management assessments and global submission timelines in a highly collaborative environment.