: Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives NRWS vision and mission. Manage... the nonclinical internal writing team including writers and quality control reviewers, and functional service providers...
. The Senior Director is responsible for managing all Regulatory activities (strategy and implementation) for assigned.../Executive Director works with a multidisciplinary team to construct a plan to develop and test key scientific hypotheses...
nonclinical toxicology studies (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines...-Clinical safety-relevant documents to support regulatory filings including initial INDs, IND annual updates, IBs, DSURs...