+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related...Responsibilities: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments...
of Statistics- CMC in our Cambridge, MA office. As a Senior Manager of Statistics, you will provide statistical leadership in the... with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC strategies to enable data...
submissions. Collaborate with regulatory affairs to address CMC-related queries and inspections from regulatory agencies...Job Description The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple...
with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability...Position Overview Bicara Therapeutics is seeking a Manager - Senior Manager of Clinical Supply Chain to lead clinical...
Job Description General/Position Summary The Package Engineering Senior Manager is an emerging professional... Pharmaceutical Sciences, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines...
members, regulatory leads, and senior management in order to advance drug candidates through research and development... and modest costs. Description of Role The Study Operational manager will manage and oversee day-to-day operations...