Senior Manager, CMC Dossier Management
About The Position
The Program Manager, CMC Dossier Management assists with developing and overseeing Chemistry, Manufacturing, and Controls (CMC) strategic project plans that support regulatory deliverables, including INDs/IMPDs and Marketing Applications. The role creates 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, maps and tracks source information supporting submission sections, and maintains accurate rosters. The position 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 and assists with identifying, monitoring, and analyzing business risks. The role recognizes when corrective action and planning are needed, conducts root cause analyses, and escalates recommendations to Program Managers, CMC RA leads, or functional area leads. It also supports functional managers with accurate resource estimates. The role coordinates teams with diverse priorities and working styles, converts goals into tasks, coordinates activities, estimates and manages requirements, and executes defined objectives while keeping management informed of progress and milestones. It provides regular submission progress updates to CMC project teams and keeps teams informed of changes to established content plans and timelines. Additional duties include training and guidance on project management practices and systems, building networks with departmental and external stakeholders, and assessing plans, processes, and practices to recommend improvements to the Manager or Director within the Dossier Management group.
Requirements
- Bachelor's degree with 12 years, master's degree with 10 years, or Ph.D. 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 CMC project teams in planning, preparing, reviewing, and approving submission documents.
- Ability to coordinate diverse teams with varying priorities and working styles.
- Experience creating and maintaining project management tools and templates to facilitate submission processes.
- Ability to contribute to cross-functional discussions about submission-related risk mitigation strategies.
- Ability to apply project management principles and techniques, prioritize tasks, and manage time effectively.
Responsibilities
- Assist in developing and overseeing CMC strategic project plans supporting regulatory deliverables such as INDs/IMPDs and Marketing Applications.
- Create regulatory submission content plans, source document maps, internal audit plans (e.g., QDP), and timelines using standardized project management tools and processes.
- Monitor regulatory submission deliverables against timelines, track source information supporting submission sections, and maintain accurate rosters.
- Create and maintain dossier content plans, source document maps, rosters, and timelines for CMC projects.
- Support multiple project plans in collaboration with CMC Regulatory Affairs and functional area leads.
- Identify, monitor, and analyze business risks; recognize when corrective action or replanning is needed; conduct root cause analyses and escalate recommendations to appropriate leads.
- Support functional managers in ensuring accurate resource estimates.
- Coordinate diverse teams and activities to achieve project goals; estimate and manage requirements, prioritize tasks, and execute defined objectives.
- Keep management informed of progress and project milestones, and provide CMC project teams with regular updates on submission progress and changes to content plans or timelines.
- Provide general training, administration, and guidance regarding project management practices and systems.
- Establish and maintain networks within the department and with external stakeholders; interact with employees at all levels in support of project coordination.
- Assess progress against plans, processes, and practices, and recommend process improvements to the Manager or Director within the Dossier Management group.
- Create and maintain project management tools and templates to facilitate the submission process.
- Contribute to cross-functional discussions about submission-related risk mitigation strategies.
- Identify opportunities for departmental work-process improvement and contribute to process improvement projects.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
