;participates with the team to achieve safety goals Reconciles Dossier financial data to Lawson general ledger. Supports the...
into Dossier, Republic Services Fleet Management Software system. Collects and interprets analyses from oil sampling, on-board...
, and administrative partners, supporting dossier preparation, documentation standards, and regulatory requirements. In addition, the...
Dossier, in collaboration with the analytical and CMC teams. Work closely with manufacturing and operations teams, monitoring...
regulatory dossiers within pre-established timelines. This includes responses to health authority inquiries, regulatory dossier... technical writer assures regulatory dossier compliance and independently authors high quality CMC content by: Supporting the...
and technical file/design dossier audits. Maintain regulatory files and tracking databases as required. Evaluate import/export...
for assigned products. Lead preparation and review of CMC dossier sections related to product quality, characterization...
reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities...
" and "Visiting Professor") until the dossier has been approved by these committees. Preferred Qualifications Current DEA...
and corrective maintenance performed, recording of all information into Dossier Maintenance Software, prepare and submit budget...