... leading and participating in global CMC (Chemistry, Manufacturing and Control) variation ... support of post approval CMC changes , preparation of technical documentation ... for global source changes CMC variations on Active Pharmaceutical Ingredients ( ...
Huta ArcelorMittal Warszawa w Warszawie (firma ...
... . Coordinate lifecycle management procedures (mostly CMC variations and Labeling changes) plus ... in alignment with EMEA Liaison, CMC-RA and or LOC. Process ... Awareness of the scientific principles (CMC, clinical and non-clinical) applicable ...
... . Coordinate lifecycle management procedures (mostly CMC variations and Labeling changes) plus ... in alignment with EMEA Liaison, CMC-RA and or LOC. Process ... Awareness of the scientific principles (CMC, clinical and non-clinical) applicable ...
... .Coordinate lifecycle management procedures (mostly CMC variations and Labeling changes)plus ... in alignment with EMEA Liaison, CMC-RA and or LOC.Process ... environmentAwareness of the scientific principles (CMC, clinical and non-clinical) applicable ...
... stanowiska:Your responsibilities: Managing multiple CMC (Chemistry, Manufacturing and Control) Variations ... the improvement opportunities for CMC Regulatory processes, policies and systemsOur ... (familiarity with post-approval CMC regulatory procedures and ICH CTD ...
... raised with stakeholders (e.g. CMC & Global Labeling, EMEA TA, LOCs ...
... , Clinical Development, Clinical Operations, Safety, CMC) incl. CRO team representatives to ...
... raised with stakeholders (e.g. CMC & Global Labeling, EMEA TA, LOCs ...
... variations for medicinal products Managing CMC (Chemistry, Manufacturing and Control) Variations ...