Senior CMC Dossier Lead: Regulatory Submissions

BioSpace; North Chicago (IL); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

AbbVie seeks a Program Manager, CMC Dossier Management to develop and oversee CMC regulatory deliverables, including INDs/IMPDs and Marketing Applications. You will coordinate content plans, source document maps, rosters, and timelines using standardized PM tools to ensure on-time submissions.

Responsibilities include monitoring submission progress, maintaining rosters, supporting cross-functional teams with risk analysis, and driving process improvements.

Qualifikationen

• Bachelor's degree plus 12 years of CMC functional experience, Master’s 10 years, or PhD 4 years in late-stage development.
• Experience in a laboratory-based CMC function to assist teams with submission documents.
• Ability to create and maintain PM tools/templates to facilitate submissions.

Aufgaben

• Assist development and oversight of CMC regulatory deliverables (INDs/IMPDs, Marketing Applications).
• Create and maintain content plans, source document maps, rosters, and timelines.
• Monitor submission progress against timelines and manage risks with root-cause analyses.

Kenntnisse

Cross-functional collaboration

Project management tools/templates

Regulatory submission knowledge

CMC experience

Ausbildung

Bachelor's degree in a relevant field

Master's degree in a relevant field

PhD in a relevant field

Jobbeschreibung

AbbVie seeks a Program Manager, CMC Dossier Management to develop and oversee CMC regulatory deliverables, including INDs/IMPDs and Marketing Applications. You will coordinate content plans, source document maps, rosters, and timelines using standardized PM tools to ensure on-time submissions.

Responsibilities include monitoring submission progress, maintaining rosters, supporting cross-functional teams with risk analysis, and driving process improvements.