Global Regulatory Affairs Lead
Skills
CTAClinical TrialsCompanion DiagnosticsIn Vitro Diagnostics
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Proficiency in in vitro diagnostics regulations specifically under US and EU jurisdictions
- Experience in drug trials utilizing biomarkers to select patients
- Ability to build diagnostic device regulatory strategy plans for biomarker-driven trials
- Up-to-date knowledge on digital health technology regulatory requirements and experience in digital pathology or health products in trials
Day to day
- Leadership responsibility for global regulatory strategy related to biomarker development and companion diagnostics
- Responsible for understanding regulatory landscapes and assessing risks
- Develops global filing strategies and co-leads submission teams for regulatory filings
- Ensures global development plans meet regulatory requirements across regions
- Contributes to cross-functional teams in response to Clinical Trial Application queries
- Provides input on protocol development and target labeling