Associate Regulatory Affairs Director – Quality, Standards & Training

Exelixis

. Provide compliance oversight for the Global Patient Safety and Regulatory Affairs functions, primarily Regulatory Affairs .

Posted 9/23/2026full-timeRemote • United StatesLead💰 $163,000 - $231,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of Regulatory Affairs within the pharmaceutical industry, with a focus on compliance oversight, performance monitoring, and process standardization. Capable of analyzing compliance metrics and supporting health authority inspections while maintaining accurate documentation and training compliance.

Highest-signal resume keywords

Regulatory Affairs ExperienceCompliance MonitoringPerformance Metrics AnalysisTraining Compliance ManagementProcess Standardization

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Framework KnowledgeCompliance OversightPerformance Indicator MonitoringRoot Cause AnalysisQuality Event TrackingHealth Authority SubmissionsSOP DevelopmentInspection ReadinessContinuous Improvement InitiativesDocument Management

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationInterpersonal SkillsProblem-Solving AbilityOrganizational Skills

Tools & Technologies

Veeva RIMLMS

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsCompliance StandardsHealth AuthorityQuality AssuranceAudits and InspectionsCAPASmPC UpdatesAggregate Report ComplianceTraining Matrices

About the role

Key responsibilities & impact

Provide compliance oversight for the Global Patient Safety and Regulatory Affairs functions, primarily Regulatory Affairs
Monitor, assess and communicate performance against compliance indicators, metrics and inspection-readiness standards
Lead compliance monitoring activities and identify compliance and operational risks
Advance process standardization, consistency and continuous improvement initiatives
Monitor SmPC updates for commercially sourced products in Exelixis-sponsored studies
Maintain accurate Reference Safety Information trackers, including health authority submission dates and approvals
Track partner IB receipt and timely health authority submissions across programs
Track RFIs to completion within SOP timelines
Monitor aggregate report compliance to health authorities and CROs
Ensure Regulatory Affairs documents in the Trial Master File and Veeva RIM remain current and complete
Monitor Regulatory Affairs training compliance via LMS
Oversee timely and accurate Regulatory Affairs SOP updates
Maintain current Regulatory Affairs points of contact for each study with health authorities
Support the Regulatory Affairs Strategy Team on development programs
Analyze compliance metrics and contribute to leadership dashboards and slide decks
Support investigation, tracking and closure of Quality Events, including root cause analysis and CAPAs
Collaborate with SMEs on deviation assessment and documentation
Coordinate impact assessments for new and evolving regulations and support implementation plans
Support health authority inspections and continuous inspection readiness
Author, review and maintain Regulatory Affairs procedures and standards
Maintain training matrices and align training requirements with procedural and regulatory expectations
Identify and conduct quality-related training for Regulatory Affairs team members
Perform other duties as assigned
Comply with all policies and standards

Requirements

What you’ll need

Bachelor's degree in related discipline and a minimum of 11 years of related experience; or Master's degree in related discipline and a minimum of 9 years of related experience; or equivalent combination of education and experience
7–10 years of regulatory affairs experience in the pharmaceutical industry
Experience with audits and inspections preferred, but not required
Extensive knowledge of the regulatory framework, industry drivers and practices
Ability to develop and manage plans, establish timelines and set standards for performance
Strong verbal and written communication skills
Strong interpersonal skills and ability to accommodate differing views to influence resolution
Ability to gather, analyze and apply key information to solve problems
Ability to proactively assess workload, trends, tasks and priorities
Ability to plan and execute multiple activities
Ability to consider alternative methods and contingency plans
10% travel required

Benefits

Comp & perks

401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in the first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Necessary equipment, including dual monitors and ergonomic chairs
Disability accommodation during the recruiting process