The Specific Pay Range For A Preferred Location
RegulatoryMaster,RegulatoryPlanningandOperations–DiagnosticsRegulatoryAffairs
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“Regulatory Master, Regulatory Planning and Operations – Diagnostics Regulatory Affairs at The Specific Pay Range For A Preferred Location. Skills: Regulatory planning, Regulatory operations, Process management, Strategic planning. Provide leadership for DRA operations. Provide strategic oversight for DRA operations”
Industry & Context.
Navigate ambiguity; Drive clarity
Occasional Travel
What They're Looking For.
Must Have
Bachelor’s degree, 12+ years regulatory affairs experience, understanding of global regulatory requirements, Demonstrated experience in regulatory operations, Demonstrated experience in process management, Demonstrated experience in strategic planning, Proven ability to lead through influence, Excellent communication skills, Excellent organizational skills, Excellent analytical skills, Excellent business acumen skills, Track record of excellent collaboration, Track record of influencing skills, Track record of facilitation skills, history of presenting complex information, Ability to navigate ambiguity, Ability to drive clarity, Ability to move work forward
Nice to Have
advanced degree preferred
What You'll Do.
Provide leadership for DRA operations
Provide strategic oversight for DRA operations
Set standards for operational excellence
Set standards for execution discipline
Set standards for departmental consistency
Provide regulatory project management
Drive operational excellence across DRA
Oversee core processes
Oversee documentation practices
Lead process related activities
Lead continuous improvement
Lead deployment of tools
Lead deployment of templates
Lead deployment of dashboards
Develop regulatory metrics
Track regulatory metrics
Report regulatory metrics
Develop regulatory KPIs
Track regulatory KPIs
Report regulatory KPIs
Provide insights for decisions
Serve as strategic partner
Translate priorities into plans
Coordinate planning cycles
Coordinate long-range strategies
Partner with stakeholders
Support workload forecasting
Support prioritization
Support lifecycle strategies
Contribute to enterprise initiatives
How You'll Work.
Team & Collaboration
DRA leadership team; GRA leadership team; Key cross functional stakeholders; Quality; R&D; Supply Chain; MSAT; Manufacturing; Program Management; Commercial
Communication Scope
Presenting complex information
Process & Methodology
Regulatory project management
Full Job Description
## **Job Description** We are seeking an experienced Regulatory Affairs leader to oversee regulatory planning and operations for Diagnostics Regulatory Affairs (DRA). This role is ideal for someone highly organized and strategically minded who can drive departmental efficiency and ensure operational excellence. S/he will be a key member of the DRA leadership team as well as the Global Regulatory Affairs (GRA) extended leadership team and serve as a key partner to the head of the department. The role blends operational leadership, process ownership, cross-functional coordination, and strategic planning to support a dynamic global IVD regulatory portfolio. **Key Responsibilities** * Provide leadership and strategic oversight for DRA operations, setting standards for operational excellence, execution discipline, and departmental consistency. * Provide strong regulatory project management for critical cross-organizational initiatives including but not limited to M&A, site or portfolio changes. * Drive operational excellence across DRA by overseeing core processes, workflows, and documentation practices. * Lead process related activities, including continuous improvement, standardization, and deployment of tools, templates, and dashboards. * Develop, track, and report regulatory metrics and KPIs, providing insights that support data-driven decisions and operational transparency. * Serve as a strategic partner within DRA LT, helping translate priorities into actionable plans and coordinating planning cycles and long-range strategies. * Partner within DRA and with key cross functional stakeholders (i.e. Quality, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and Commercial) to support planning, workload forecasting, prioritization, and lifecycle strategies. * Contribute to enterprise-level initiatives requiring DRA operational leadership or strategic input. ## ## **Qualifications** * Bachelor’s degree in a scientific discipline; advanced degree preferred. * 12
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