Senior Director of Regulatory Operations - Remote

Overview

The Senior Director of Regulatory Operations (RO) will be responsible for independently managing multiple operational components of regulatory submission production, maintenance processes, and/or Information Management in support of Arcus’s product portfolio. This position will also independently develop, implement, maintain and manage the submission strategy for areas of responsibility in alignment with the global Regulatory strategy.

In Short

• Leadership role in the development of compliant GXP electronic systems and paper methods.
• Monitors business trends and develops action plans accordingly.
• Supports budgeting and forecasting activities.
• Oversees vendor management for regulatory submissions.
• Ensures timely delivery of submission documents.
• Collaborates with stakeholders for major submissions.
• Manages worldwide regulatory electronic and paper submissions.
• Develops KPIs and analytics for Regulatory Strategy.
• Engages with regulatory agencies for guidance and regulations.
• Maintains document standards and templates for submissions.

Requirements

• Bachelor’s or Master’s degree in Life Science or related discipline.
• 12 years (Bachelor's) or 10 years (Master's) regulatory experience.
• Minimum of 6 years in a regulatory operations leadership role.
• Strong written and verbal communication skills.
• Ability to work independently on multiple projects.
• Detail oriented with problem-solving skills.
• Experience with electronic submissions and publishing tools.
• Exceptional interpersonal skills.
• Project planning and management skills.
• Knowledge of U.S. and international regulations.

Benefits

• Competitive salary with stock program participation.
• Performance-based bonus.
• Comprehensive benefits package.
• Opportunity for professional development.
• Supportive work environment focused on continuous improvement.