are properly and timely implemented Provide support to Regulatory CMC managers in developing strategy for development projects..., including assigned projects and back-up projects Participate in CMC project team meetings and provide Regulatory CMC support...
projects. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC... of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Affairs...
execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the... preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics...
execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the... preparation and submission of regulatory CMC documentation and manages interactions with Health Authorities for CMC topics...
, biologics, cell therapies, and other drug modalities. Collaborate with Global Manufacturing, Regulatory Affairs, and Global... at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here, everyone matters and you will be a vital...
& Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives..., through registration, clinical trials, and commercial launch Advanced knowledge of cGMPs and associated CMC regulatory...
-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality...Job Description General Summary: The Quality Control Senior Manager will be responsible for supporting the...
, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine’s/Vertex...Job Description General Summary: The Quality Control Manager will be responsible for supporting the establishment...
for CMC regulatory filings for the overall process control strategy for commercializing new programs and maintenance through.... This will include working closely with cross-functional teams in VCGT, Regulatory Affairs, Supply Chain and Manufacturing Operations...
of CMC strategies across Therapeutic Area Units (TAU) by providing leadership, coaching and guidance to PS program leaders..., analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs...