of Regulatory Affairs CMC, the Director, Global Regulatory Affairs - CMC is responsible for owning and leading the global CMC...'s products. This individual ensures that global CMC regulatory requirements are proactively identified, strategically addressed...
of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA... preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier...
We are seeking an experienced and strategic Senior Director, Regulatory Affairs - CMC to lead global CMC regulatory... commercialization. This role is a key leadership position within the Regulatory organization and will serve as the global CMC...
and other presentations . About the Role Associate Director, Regulatory Affairs CMC As the Associate Director, Regulatory Affairs CMC..., reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC...
from chronic management to single-course gene editing medicines. Position Summary: The Associate Director, Regulatory CMC... will work closely with cross-functional subject matter experts to provide strategic and operational input for CMC regulatory...
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...
to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline...Senior Director, Regulatory Affairs - Boston, MA We're partnering with a leading Boston-based oncology biotech...
Manager, Regulatory Affairs Operations, to join our team. Reporting to the Director, Regulatory Affairs, this individual...-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance. Skills...
, regulatory affairs, and manufacturing, to ensure seamless integration and success. Qualifications Ph.D. in biochemical... and working with global teams and external CDMO's Knowledge of Quality by Design principles, cGMP, and CMC requirements...
leadership and program management for multiple global CMC development teams dealing with complex development programs..., pharmaceutics, quality assurance and/or regulatory affairs. Advanced understanding in DMPK, Pharmacology and Toxicology. Extensive...