Global Regulatory Operations Director - Remote

Jobvite, Inc.; Hayward (CA); Remote; USD 265,000 - 295,000; Full time

Benefits offered by this job

Stock programs

Performance-based bonus

Comprehensive benefits package

Job summary

Arcus Biosciences seeks a Senior Director of Regulatory Operations to independently manage multiple submission production and information management components in support of our product portfolio. This role aligns submission strategy with the global Regulatory strategy and reports to the VP of Regulatory Affairs.

The position oversees global regulatory submissions, publishing, archiving, and information management, coordinating with IT for platforms, and driving KPIs to optimize regulatory

Qualifications

• Bachelor or Master degree in Life Science with 10–12 years regulatory experience.
• 6+ years in regulatory operations leadership.
• Strong leadership and people management skills.
• Excellent written and verbal communication.
• Ability to manage multiple projects with moderate supervision.
• Knowledge of US and international regulations and guidelines.
• Experience with electronic submissions (eCTD) and publishing tools.
• Experience with Veeva Vault or similar DM systems.

Responsibilities

• Lead compliant GXP electronic systems and paper submission methods.
• Monitor regulations, develop action plans and tools.
• Support budgeting and vendor contract expenditures for submissions.
• Manage resourcing and contracting for external Regulatory Operations tasks.
• Coordinate submission planning, timelines and quality standards.
• Oversee worldwide electronic and paper submissions and readiness.
• Collaborate with stakeholders on major submissions and forecasts.
• Oversee disclosure and data sharing coordination with regulators.
• Ensure training and SOP development with other teams.
• Develop KPIs and analytics to drive Regulatory Strategy.

Skills

Leadership in management

Team player

Strong communication skills

Independent work

Detail oriented

Problem solving

Interpersonal skills

Project planning

Education

Bachelor’s degree in Life Science

Master’s degree in Life Science

Tools

ISI Toolbox

Veeva Vault for Submissions

Document Management Systems

Job description

Arcus Biosciences seeks a Senior Director of Regulatory Operations to independently manage multiple submission production and information management components in support of our product portfolio. This role aligns submission strategy with the global Regulatory strategy and reports to the VP of Regulatory Affairs.

The position oversees global regulatory submissions, publishing, archiving, and information management, coordinating with IT for platforms, and driving KPIs to optimize regulatory