Director Regulatory CMC Sciences Project Management
Core
Director leading regulatory project management for global, large-scale manufacturing site transfers and alternate API sourcing activities to ensure supply continuity.
Role type
Senior IC regulatory project management director
Builds
Regulatory submission packages and supply continuity plans for complex manufacturing site transfers and alternate sourcing
Domain
Healthcare / Pharmaceutical Regulatory Affairs / CMC Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
CMC authoring, complex regulatory project management, site transfer strategy, alternate API sourcing, gap assessment, regulatory risk management, stakeholder alignment, Change Control, strategic planning, team leadership
Preferred skills
Matrixed team management, scientific/technical resource consultation, dashboard development, global regulatory requirements expertise
Technologies
Microsoft Office Suite, Documentum
Responsibilities
Provide regulatory project management support for global network optimization projects; Coordinate priorities across multiple projects for submission planning and forecasting; Lead oversight of contracted GRA resources; Cultivate relationships with internal stakeholders to drive regulatory assessments and mitigation plans; Use technical knowledge to assure regulatory compliance and support submission preparation; Present issues for resolution and mentor colleagues; Develop dashboards and metrics for reporting; Serve as single Point of Contact for a large portfolio of projects
Seniority
Director, strategic leadership & hands-on management