. Familiarity with CTD structure and terminology, and CMC technical content. Prior experience in a lead, reviewer, or quality...
. Familiarity with CTD structure and terminology, and CMC technical content. Prior experience in a lead, reviewer, or quality...
development, including nonclinical, CMC, regulatory, and early clinical activities. Experience working in GxP-regulated... involves close collaboration with cross-functional teams across research, nonclinical, CMC, regulatory, clinical, finance...
development, including nonclinical, CMC, regulatory, and early clinical activities. Experience working in GxP-regulated... involves close collaboration with cross-functional teams across research, nonclinical, CMC, regulatory, clinical, finance...
and external stakeholders to maintain compliance and prevent business delays due to regulatory issues. Provide regulatory CMC...
storage of gene therapy R&D and CMC development materials. The position is hybrid, requiring approximately 1-2 days per week...
and Chemistry, Manufacturing, and Controls (CMC) activities. Experience with LIMS and electronic laboratory documentation...
or review CMC sections related to raw materials and single-use systems. Support IND, BLA, MAA, and post approval submissions...
-adjacent tool validation documentation and data standards harmonization across programs Regulatory and CMC support Generate... data for regulatory submissions Support process characterization omics analyses for CMC packages Conference...
and authoring of CMC/regulatory sections for IND submissions. Qualifications Demonstrated experience successfully planning...