Overview In this role you will lead Regulatory Operations to manage submission production, archiving, and information management for Arcus's product portfolio. You'll shape and execute the submission strategy in line with global regulatory goals and coordinate cross-functional teams to ensure timely, compliant submissions. You'll oversee electronic and paper publishing, systems, outsourcing, and vendor coordination to support global submissions and inspection readiness. This is a strategic, data driven role with impact on regulatory compliance and business execution.
Compensation / Benefits- stock programs
- performance-based bonus
- comprehensive benefits package
- remote work option
Responsibilities- Lead compliant GXP electronic systems and paper submission methods; plan, prepare, and track regulatory documents and submissions to meet requirements and timelines
- Monitor regulatory trends, guidance, and technologies; develop action plans and tools
- Assist with budgeting, forecasting, and vendor contracts for outsourcing regulatory submissions
- Coordinate resourcing and contracting for external Regulatory Operations tasks; manage vendor delivery
- Collaborate with cross-functional stakeholders to plan major submissions and global rollout; forecast resource needs
- Oversee submission formatting, style guide, and glossary to ensure consistency and quality
- Identify and implement submission preparation software; define requirements and manage lifecycle of these systems
- Engage with regulatory agencies on new guidance; analyze impact and ensure preparedness
- Develop SOPs to standardize Regulatory Operations and cross-team coordination
- Maintain knowledge of eCTD, NeeS, and paper submissions; ensure templates and archiving standards
- Develop KPIs and analytics to drive Regulatory Strategy
Key requirements- Bachelor's degree in Life Science or related discipline with 12 years regulatory experience or Master's degree with 10 years regulatory experience
- Minimum 6 years in a regulatory operations leadership role
- Experience with electronic submissions (eCTD) and publishing tools (ISI Toolbox and templates)
- Experience with Veeva Vault for Submissions or similar Document Management Systems
- Strong leadership, communication, and project planning skills
- Working knowledge of US and international regulatory requirements
- Ability to manage multiple projects independently in a fast-paced environment
- Detail-oriented with problem-solving and troubleshooting skills
- Strong stakeholder management and collaboration abilities
- leadership
- team collaboration
- exceptional communication skills
- eCTD submissions
- ISI Toolbox
- Veeva Vault for Submissions
