Remote Senior Director, Regulatory Operations & Submissions

Arcus Biosciences, Inc.; Brisbane (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, Inc. seeks a Senior Director of Regulatory Operations to independently manage submission production, maintenance processes, and information management across the product portfolio.

You will develop and implement the submission strategy in alignment with global Regulatory strategy and ensure compliant, timely delivery of global submissions. The role leads regulatory operations teams, collaborates across departments, and interfaces with IT for platform enablement.

Qualifications

• Bachelor’s degree in Life Science or related discipline with 12+ years regulatory experience or Master’s degree with 10+ years regulatory experience.
• 6+ years’ experience in a regulatory operations leadership role.
• Leadership skills in managing people.
• Strong written and verbal communication skills.
• Ability to work independently with moderate supervision on multiple projects simultaneously.
• Detail oriented with creative problem solving and troubleshooting skills.
• Working knowledge of applicable U.S. and international regulations and guidelines.
• Experience with electronic submissions (eCTD) and publishing tools, ISI Toolbox, and templates.
• Experience with Veeva Vault for Submissions and/or other Document Management Systems.

Responsibilities

• Lead the development of compliant GXP electronic systems and paper methods; plan, prepare, and track regulatory documents and submissions.
• Monitor regulatory trends and guidance to inform operations impact and action plans.
• Support budgeting and forecasting, including vendor contracts for outsourcing submissions.
• Coordinate vendors and resources to ensure on-time delivery of submissions.
• Partner with other departments to ensure high-quality submissions and regulatory readiness.
• Oversee worldwide electronic and paper submissions and ensure timelines and quality standards.
• Collaborate on major submissions and global rollout plans with stakeholders.
• Organize cross-functional meetings to coordinate submission Planning.
• Manage formatting style guide and glossary for consistent submission documents.
• Lead the identification and implementation of submission preparation software.
• Develop KPIs and analytics to advance regulatory strategy.

Skills

Leadership

Team player

Written communication

Verbal communication

Independent working

Detail oriented

Problem solving

Regulatory knowledge

Project planning

Education

Bachelor's degree in Life Science or related field

Master's degree in Life Science or related field

Tools

ISI Toolbox

Veeva Vault for Submissions

Document Management Systems

Job description

Arcus Biosciences, Inc. seeks a Senior Director of Regulatory Operations to independently manage submission production, maintenance processes, and information management across the product portfolio.

You will develop and implement the submission strategy in alignment with global Regulatory strategy and ensure compliant, timely delivery of global submissions. The role leads regulatory operations teams, collaborates across departments, and interfaces with IT for platform enablement.