Director – Regulatory Affairs, Analytics and Insights Lead

• Own the data quality, infrastructure, and business practices related to resource management.
• Leads special projects and pilots that advance the capabilities of RA Business Operations.
• Provide support across Business Operations capabilities as needed (Vendor Management, Business Process Excellence, Inspection Readiness, Business Process Excellence, Change Management, Communications and Engagement)
• Makes significant contributions to short- and long-range RA strategies, plans, and infrastructure development, and Development, RSQ and RA-wide initiatives and evolutions.
• Collaborate within Human Capital (Resource Management and Vendor Management) to drive holistic internal/external resourcing strategies across RA.
• Embed resource management concepts and influence the culture and practices across RA as it pertains to managing demand, increasing capacity, developing talent in line with strategy, and creative solutioning.
• Build relationships and trust with a network of leaders and sub-functional spoke contacts to influence and deliver the goals of resource management and Business Operations.
• Manage difficult conversations including headcount discussions, prioritization, and interrogation of data quality.
• Lead yearly Strategic Workforce Planning cycles in partnership with Head of Human Capital.
• Track and drive changes to address gaps identified in workforce.
• Oversee the maintenance of algorithmic forecasting (Planisware) in collaboration with others on the Human Capital team to improve algorithm accuracy and leadership understanding of resource trends.
• Orchestrate across RA leadership, Finance (LE cycles) and HR to enable the workforce needed to drive our portfolio.
• Aligns resource data and planning efforts to facilitate decision-making forums, including capacity planning and initiative review meetings.
• Provides guidance and recommendations, based on data, of the future resource needs for latest estimate/year end processes, etc. for Regulatory Affairs functional areas as needed.
• This role is the consultant to the business on all things resourcing related.
• Partners with the Regulatory Affairs Leadership Team to develop mitigation plans to address gaps in demand and capacity in collaboration with the Human Capital Lead and Vendor Governance.
• Provides formal and informal training of resource concepts, processes, tools, and reports.
• Oversee technical administration of Planisware and Smartsheet Resource Manager tools in collaboration with Human Capital team members and Performance Excellence Infrastructure Lead.
• Continual improvement and maturation of Resource Management capability.
• Develop performance and resource management guidelines and training materials for team leads and project managers.

• MA / MS / MPH with 10+ years of Regulatory Affairs, resource and/or project management OR 8+ years with a PhD with relevant experience OR a BA / BS with 12+ years Regulatory Affairs, resource and/or project management
• Experience managing complex projects and implementations
• Planisware, Smartsheet (including Resource Manager, Control Center), or other named resourcing experience required
  
  Knowledge of resourcing and forecasting methods and applicable tools for tracking and forecasting needs
• Preferred candidates will demonstrate relevant cross-Business Operations skillsets beyond Resource Management including Performance Management, Business Process Excellence, Change Management, Communications and Engagement, etc.
• Experience creating insightful reports, presentations, and forecasts that allow for actionable, strategic decision making
• Strong understanding of the research and drug development life cycle processes, roles and systems required
• Ability to influence and drive decisions without direct authority
• Demonstrated negotiation, problem solving, critical thinking and facilitation skills
• Strong quantitative reasoning and analytical ability
• History of motivating others with a positive attitude to deliver to important milestones while maintaining a positive, transparent, and collaborative team environment
• Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with cross functional team members
• Ability to proactively gather, interpret and evaluate information from a variety of resources to make decisions and recommendations
• Proven ability to multitask in order of priority in a deadline driven environment with optimal efficiency and accuracy
• Ability to communicate in a clear and concise manner
• Ability to support a team-oriented, highly matrixed environment
• Ability to execute multiple tasks as assigned
• When needed, ability to travel.

Demonstrates expertise in Resource Management, Regulatory Affairs, and Project Management, with a strong focus on data quality, forecasting methods, and strategic decision-making. Proven ability to lead complex projects, influence cross-functional teams, and develop training materials to enhance operational capabilities.