Lead Regulatory Affairs Manager, International
Exact SciencesCologne, North Rhine-Westphalia, Germany • London, England, United Kingdom • Sweden • Milan, Lombardy, Italy
Posted March 20, 2026
Full Time
About the Company
Exact Sciences is a purpose-driven company changing lives by preventing, detecting, and guiding treatment for cancer.
Job Description
Help us change lives at Exact Sciences, where we're changing the world by preventing, detecting, and guiding treatment for cancer. We're seeking a Lead Regulatory Affairs Manager, International to support the creation and submission of product Technical Files and other documents for market authorizations in targeted markets and countries.
Requirements
- Prepare and maintain regulatory submissions and premarket registrations
- Develop and execute regulatory strategy for assigned projects
- Create and implement global regulatory affairs procedures
- Represent Regulatory Affairs on project teams
- Manage distributors and RA consultants
- Review and approve documents and product changes for regulatory compliance
- Review technical publications and articles to stay abreast of regulatory and technical developments
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
- Relocation Assistance
