Senior Manager, CMC Dossier Management

📋 Description

• Lead and oversee the development of Chemistry, Manufacturing, and Controls (CMC) strategic project
• Monitor progress of regulatory submission deliverables against timelines; map and track source
• Provide dossier support to CMC projects team including creation and maintenance of content plans
• Collaborate with CMC RA and functional area leads to maintain multiple project plans; identify
• Identify opportunities for process improvement; convert goals to tasks, coordinate activities, and
• Apply project management principles to coordination and completion of assigned goals; prioritize

🎯 Requirements

• Bachelors with 12, Masters with 10, or PhD with 4 years of CMC functional experience including
• Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation
• Ability to create and maintain project management tools/templates to facilitate the submission
• Contribution to cross-functional discussions around submission-related risk mitigation strategies.