Senior Manager, CMC Dossier Management
About The Position
The Program Manager, CMC Dossier Management supports the development and oversight of Chemistry, Manufacturing, and Controls (CMC) strategic project plans for regulatory deliverables, including INDs/IMPDs and Marketing Applications. The role develops regulatory submission content plans, source document maps, internal audit plans (such as QDP), and timelines using standardized project management tools and processes. It monitors submission deliverables against timelines, tracks source information supporting regulatory sections, and maintains accurate rosters. The role provides dossier support to CMC project teams by creating and maintaining content plans, source document maps, rosters, and timelines. In collaboration with CMC Regulatory Affairs and functional area leads, it supports multiple project plans, identifies and analyzes business risks, and recognizes when corrective action or root cause analysis is needed, escalating recommendations to relevant leads. It also supports functional managers with accurate resource estimates. The position coordinates diverse teams, manages tasks and objectives, communicates progress and milestones to management, and keeps CMC project teams informed of submission progress and changes to plans or timelines. It provides training and guidance on project management practices and systems, builds stakeholder networks, and assesses plans and processes to recommend improvements to Dossier Management leadership.
Requirements
- Bachelor’s degree with 12 years, master’s degree with 10 years, or PhD with 4 years of CMC functional experience, including late-stage development experience.
- Prior experience in a relevant laboratory-based CMC function, such as chemistry, analytical, or formulation, to support planning, preparation, review, and approval of submission documents.
- Ability to create and maintain project management tools and templates to facilitate the submission process.
- Ability to contribute to cross-functional discussions about submission-related risk mitigation strategies.
- Skill coordinating diverse teams with varying priorities and working styles.
- Ability to apply project management principles and techniques, prioritize tasks, and manage time effectively.
Responsibilities
- Develop and oversee CMC strategic project plans for regulatory deliverables, including INDs/IMPDs and Marketing Applications.
- Create and maintain regulatory submission content plans, source document maps, internal audit plans, timelines, and project rosters.
- Monitor submission deliverables against timelines and track source information supporting regulatory submission sections.
- Support multiple project plans in collaboration with CMC Regulatory Affairs and functional area leads.
- Identify, monitor, and analyze business risks; recognize the need for corrective action and root cause analysis, and escalate recommendations to relevant leads.
- Support functional managers in developing accurate resource estimates.
- Coordinate diverse teams and activities to achieve project goals and defined objectives.
- Provide regular updates to CMC project teams on submission progress and changes to content plans or timelines.
- Provide training support, administration, and guidance on project management practices and systems.
- Establish and maintain networks within the department and with external stakeholders, interacting with employees at all levels.
- Assess progress against plans, processes, and practices, and recommend process improvements to the Manager or Director within the Dossier Management group.
- Identify opportunities for departmental work-process improvement and contribute to process-improvement projects.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
