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 as needed, including update to the teams on follow-up...
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...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the... preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics...
a Bachelor's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices or a related scientific or allied health...Job Description JOB TITLE: Sr. Quality Manager LOCATION: 1 Harbor Street, Boston, MA 02210 OPENINGS: 1 DUTIES...
Quality Lead in CMC, Program, and CSP team meetings to provide strategic direction and leadership to product development... with Regulatory Affairs to review, and approve regulatory filings (IND, NDA) Support pre-approval inspection and commercial readiness...
& 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...
expectations and influencing others Working with cross functional team including Clinical Operations, Regulatory Affairs and QA...Job Description General Summary: The Clinical Supply Chain Manager is responsible for forecasting, packaging...