Director - Regulatory Affairs Resource, Analytics and Insights Lead

About the role

This role reports into the head of RA Human Capital which sits within RA Business Operations. RA Business Operations is a strategic partner and advisor to other Regulatory Affairs functions and teams and their partners and stakeholders. The role involves owning the data quality, infrastructure, and business practices related to resource management, leading special projects, and collaborating within Human Capital and Business Operations.

Responsibilities

• Own the data quality, infrastructure, and business practices related to resource management.
• Lead 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.
• 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.
• 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.
• 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.
• Oversees 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.

Requirements

• Minimum Education: 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.
• 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.
• Past 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.

Salary Range

The salary range for this position is $191,250.00 - $247,500.00. Bay Area: $210,375.00 - $272,250.00.

Benefits

Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit here.