Your Responsibilities Lead the global Regulatory Affairs CMC strategy for development and registration programs. Drive the preparation and review of high-quality CMC documentation (Module 3) for global regulatory submissions. Support and coordinate IND, IMPD, NDA and MAA submissions throughout the product lifecycle. Act as the Regulatory CMC expert in cross-functional project teams, collaborating closely with CMC Development, Analytical Development, Manufacturing, Quality and external partners. Provide strategic regulatory guidance for CMC changes, lifecycle management and health authority interactions. Contribute to regulatory risk assessments and the overall development strategy. Build strong relationships with internal stakeholders and external regulatory partners. Support the further development of Regulatory Affairs CMC capabilities within the organization.
Innovative Biopharmaceutical Company | Northwestern Switzerland Shape the Regulatory Future of Innovative Small Molecule Therapies Our client is an innovative and fast-growing biopharmaceutical company developing breakthrough therapies for patients with high unmet medical needs.
