Senior Regulatory Operations Manager

Exelixis

. Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management .

Posted 11/11/2026full-timeRemote • California • United StatesSenior💰 $165,000 - $208,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submission planning and publishing, with proficiency in eCTD structure and document management technologies. Capable of managing submission objectives and ensuring compliance with evolving regulatory standards.

Highest-signal resume keywords

Regulatory Submission PlanningECTD Technical ExpertiseVeeva RIM ManagementRegulatory Publishing TechnologiesDocument Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Submission ManagementQuality ControlDocument FormattingTechnical ValidationSubmission Lifecycle Management

Soft Skills

Effective CommunicationInterpersonal SkillsProblem SolvingTime ManagementCollaboration

Tools & Technologies

Veeva Vault RIMLORENZ DocubridgeMicrosoft WordAdobe AcrobatRegulatory Validation Tools

Industry Keywords

Regulatory FrameworkHealth Authority SubmissionsSOPsBest PracticesIndustry Practices

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management
Provide eCTD technical expertise and manage submission plans in Veeva RIM
Format, publish, transmit and archive Health Authority submissions
Serve as subject matter expert for regulatory publishing and document management technologies
Provide guidance on eCTD structure, content readiness, publishing, validation, dispatch and lifecycle management
Perform document- and submission-level technical quality control
Identify IT solutions, automation opportunities and technology enhancements for Regulatory Operations
Create regulatory submission objectives, content plans and documentation within Veeva RIM
Review evolving FDA electronic submission requirements and technical standards and implement changes
Collaborate on SOPs, work instructions, templates, checklists, standards and best practices
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 nine years of related experience; or Master’s degree and a minimum of seven years; or PhD and a minimum of two years; or equivalent combination of education and experience
Subject matter expertise in regulatory publishing and document management technologies, including LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools
Knowledge of regulatory framework and industry practices
Ability to manage time and resources and complete tasks within established timelines
Clear and effective verbal and written communication
Good interpersonal and collaborative skills
Ability to gather, analyze and apply information to solve problems
Ability to manage and execute own work with integrity
Approximately 20% travel

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
Reasonable accommodations for qualified individuals with disabilities