Regulatory Project Manager managing CMC regulatory projects for a devices portfolio at GSK. Collaborating with teams across supply, technical, and quality to ensure regulatory compliance.
About the role
- Experienced Project Manager managing complex architectural projects at CetraRuddy. Leading project teams and ensuring alignment between design intent and execution throughout all phases.
Responsibilities
- Serve as the Project Manager responsible for overall project delivery, reporting directly to the Principal in charge.
- Own project scope, schedule, budget, staffing plans, and fee management across all phases.
- Lead project planning efforts, including work plans, consultant coordination, and construction planning.
- Actively manage risk, change orders, and scope adjustments to protect project and firm performance.
- Serve as the primary point of contact for clients, leading communication, decision-making, and issue resolution.
- Lead and mentor project teams, including Project Architects and production staff, ensuring clear direction, accountability, and workflow.
- Coordinate consultants and external partners to maintain alignment with project goals, schedule, and deliverables.
- Foster team cohesion, efficiency, and a high standard of execution.
- Provide oversight of design development and technical documentation to ensure quality, coordination, and code compliance.
- Review drawings and specifications for completeness, accuracy, and constructability.
- Maintain sufficient hands-on capability to step into production when required, including the development of drawing sets.
- Participate in site visits to assess progress, resolve issues, and ensure design intent is maintained.
Requirements
- Professional Architecture Degree. Master's preferred, but not required.
- 12+ years of related experience.
- Licensure is preferred. If not licensed, must be actively pursuing or on a defined path toward licensure.
- Demonstrated ability to manage complex architectural projects.
- Demonstrated knowledge of 3D modeling & BIM documentation tools, including Revit and the Adobe Suite.
- Demonstrated knowledge of building codes, zoning, jurisdictional processes, building materials, specifications, and construction techniques.
- Demonstrated experience developing CD Sets, including detailing ability and coordination of consultants.
- An attitude and commitment to being an active participant in the culture of the studio.
Benefits
- Comprehensive benefits package
- Hybrid optional working environment on Mondays and Fridays
- Professional development opportunities
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