Associate Director, Regulatory Operations
Core
Lead global regulatory submission planning, tracking, and lifecycle management to ensure alignment with health authority requirements and corporate objectives.
Role type
Senior IC regulatory operations manager (Veeva RIM SME)
Builds
Integrated regulatory plans, submission tracking systems, and operational processes for global drug development programs.
Domain
Pharmaceutical/Biotech regulatory operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory submission planning, Veeva RIM expertise, data governance, SOP development, cross-functional project management, process harmonization, KPI monitoring, training delivery
Preferred skills
Lean/Six Sigma, Microsoft Project/Smartsheet, change management, analytical capabilities
Technologies
Veeva RIM, Microsoft Word, Excel, PowerPoint, Microsoft Project, Smartsheet
Responsibilities
Develop integrated regulatory plans aligned with global strategies; ensure compliance with global regulatory requirements; partner with Regulatory Affairs leads to translate strategies into actionable plans; support Health Authority interaction tracking; enable structured tracking of regulatory objectives; serve as SME for Veeva RIM modules; lead continuous improvement initiatives; create and manage project plans; support system upgrades and validation; establish data standards; oversee end-to-end submission planning; design and maintain SOPs; monitor KPIs related to submission performance.
Seniority
Senior, hands-on IC