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Director – Regulatory Affairs, Analytics and Insights Lead
Gilead SciencesDirector of Regulatory Affairs at Gilead leading resource management and analytics initiatives to meet health challenges. Collaborating with teams to ensure quality and compliance in strategic planning.
Posted 7/14/2026full-timeFoster City • California, New Jersey • 🇺🇸 United StatesSenior💰 $191,250 - $247,500 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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.
Highest-signal resume keywords
Regulatory Affairs ExperiencePlanisware ProficiencyProject Management SkillsData Analysis and ForecastingChange Management Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Resource ManagementProject ManagementData AnalysisForecasting MethodsPerformance ManagementBusiness Process ExcellenceNegotiation SkillsQuantitative ReasoningAnalytical AbilityReport Creation
Soft Skills
Influencing Without AuthorityProblem SolvingCritical ThinkingRelationship ManagementTeam Collaboration
Tools & Technologies
PlaniswareSmartsheetResource ManagerControl Center
Industry Keywords
Regulatory AffairsDrug Development Life CycleBusiness OperationsChange ManagementInspection Readiness
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives (eligibility may vary based on role)
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans