Senior Principal, Regulatory Affairs - Companion Diagnostics - Remote

Overview

The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment.

In Short

• Lead regulatory strategy and execution for external partnerships and product lifecycle management.
• Innovate, communicate, and execute strategic regulatory plans.
• Maintain regulatory intelligence and ensure internal procedures are updated.
• Develop and manage regulatory submissions including documentation and timelines.
• Collaborate cross-functionally with Clinical Affairs, R&D, QA, and Business Development.
• Provide device-specific regulatory insight during cross-functional meetings.
• Mentor the organization in key regulatory activities.
• Support product commercialization in multiple regions.
• Adapt strategies based on evolving information and priorities.
• Ability to travel approximately 25%.

Requirements

• Bachelor’s, Master’s, or PhD in a scientific or engineering discipline.
• In-depth knowledge of FDA and EU regulatory requirements for Companion Diagnostics.
• Extensive experience developing regulatory strategies for high-complexity diagnostic products.
• Proven track record supporting new product development and complex clinical trials.
• Excellent collaboration skills within multi-stakeholder programs.
• Good understanding of Global Regulatory Strategy in Drug and Device Development.
• Experience communicating regulatory strategies to senior leadership.
• Experience with drug development and regulatory procedures is a plus.

Benefits

• Comprehensive health care programs.
• Paid time off.
• Flexible remote working arrangements.
• Enriching careers and professional development opportunities.
• Diversity and inclusion initiatives.