CMC Purpose of the function: The Global Strategy RACMC Department is part of the Global RACMC department... regulatory affairs (CMC) strategy for all late-stage and commercial products including the 5 main ADC programs but also early...
functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to support your team to solve... of your team and you are able to develop people on a personal and professional level You are able to interact with management...
topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc. You have a proven track record as team leader... with fast decision-making processes and a lot of potential for your personal development Individual development and training...
For our Global Regulatory Affairs department, we are looking for a Global Regulatory Affairs CMC Manager / Senior..., from preclinical to post approval phase? The Global Regulatory Affairs CMC department is responsible to oversee all relevant...
and validation activities across the projects for Drug Product manufacturing, evaluates CMC risks for appropriate escalation... and manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions. Manage timelines, deliverables...
You are responsible as leader for a team of 4-6 people You work together with different functions from global QA, CMC, Regulatory Affairs... on a personal and professional level You are able to interact with management level at CMOs and in case necessary you take over...
, or equivalent qualifications) Experience in Regulatory Affairs and/or experience in quality/compliance/clinical/safety/CMC... required (oral and written) You’ll receive: Sandoz has an employee-first approach and that’s why your personal growth is so...
of tech transfer and validation activities across the projects for monoclonal antibody manufacturing, evaluates CMC risks... Communicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions...