and modest costs. Description of Role The Executive Director, Regulatory CMC will provide strategic leadership for global CMC.... Work Location The Executive Director, Regulatory CMC role is a remote role based in the US, with occasional travel...
and modest costs. Description of Role Our Associate Director, Regulatory Affairs Reporting will be responsible for performing... and managing key regulatory activities that are compliant with US, ex-US, and company standards. Reporting to the Executive...
heart of the company's clinical and CMC strategy, working directly with executive leadership to drive regulatory success..., and FDA interactions Own regulatory planning for Phase I-III clinical development and registration Guide CMC regulatory...
across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality standards... and cross-functional development processes (Clinical, CMC, Regulatory, QA, Biostats, Commercial) PMP or equivalent project...
with Clinical Operations, CMC, Quality, Regulatory, Finance, and external vendors. Reporting to the Senior Director, Clinical Supply...: Collaborate with Quality, Clinical, CMC and external CDMOs to develop and approve clinical labels. Manage CDMO packaging/labeling...