Job Description The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets... in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes...
Make your mark for patients We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team... do Responsible for authoring regional and globalCMC documentation for submissions in line with agreed global regulatory strategy...
entire network of Eurofins companies. Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution... across functions and collaborate with colleagues from diverse technical backgrounds. Experience in or exposure to multiple CMC...
entire network of Eurofins companies. Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution... across functions and collaborate with colleagues from diverse technical backgrounds. Experience in or exposure to multiple CMC...
, PV and GMP-related obligations in the UK, EU and global markets. Role summary The Senior Manager / Associate Director... Clinical development and global submissions Manage preparation and submission of CTAs and associated maintenance (substantial...
, MA maintenance, PV and GMP-related obligations in the UK, EU and global markets. Role summary The Regulatory Affairs Director...) and driving high-quality authoring and critical review of CTD modules (clinical, CMC, non-clinical), while also contributing to BD...
readiness, including data reviews, CMC section checks, and archiving maintenance. Represents the laboratory during audits..., and cross-functional opportunities within Catalent’s global network. Benefit from a subscription to LinkedIn Learning, providing...
Liverpool street) 5 days on site per week. Responsibilities: Partnering closely with the CMC Connect team to support global...A fantastic opportunity has opened at CMC Markets for a Institutional Trade Support Analyst to join our London-based...
global development and registration in coordination with US colleagues Collaborate closely with the Reg CMC lead for the...Location: London, UK Reporting to: VP, Regulatory Science Orchard Therapeutics, a Kyowa Kirin company, is a global...
Global Head of Regulatory Strategy & Labelling Location: Cambridge, Hybrid - Open to remote working Department..., healthcare professionals, our partners, and our employees. The Team Global Head of Regulatory Strategy & Labelling...