, or a related scientific/technical discipline. Minimum of 3 years' hands-on Regulatory/CMC authoring experience (initial...
. Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC...
of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high... with overall CMC and Pharmaceutical Development strategy. Serve as the analytical CMC lead for assigned programs, providing clear...
and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related...
or Chemical Engineering. Experience of authoring CMC sections of regulatory submissions...
, Regulatory/CMC, legal, Quality requirements and import/export policies Demonstrated understanding of drug development...
, Regulatory/CMC, legal, Quality requirements and import/export policies. Demonstrated understanding of drug development...