of global regulatory submission sections, for late-stage and commercial programs as analytical method Subject Matter Expert (SME... writing, especially regulatory documents (e.g. BLA and RoW submission) is MUST HAVE. Experience in analytical development...
ICH and regulatory guidelines and good understanding of GMP concept for the safety methods Excellent technical writing skills...Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety...