Director - Regulatory Affairs Resource, Analytics and Insights Lead

Function

This role reports into the head of RA Human Capital which sits within RA Business Operations. RA Business Operations is key group within the broader global Regulatory Affairs organization and is a strategic partner and advisor to other Regulatory Affairs functions and teams and their partners and stakeholders.

Overview

RA Business Operations helps ensure that the worldwide Regulatory Affairs organization operates with the highest standards of quality, efficiency and compliance, while further supporting strategic decision-making and continuous improvement. RA Business Operations provides a broad range of expertise and services such as: operational excellence, best practices, knowledge management, business process and continuous improvement, performance metric setting and reporting, quality and compliance monitoring and reporting, vendor and resource management, training and education for RA colleagues and their partners and stakeholders, and more.

Example 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.

Salary Range

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