RemotevilleRemote Global Regulatory Affairs Lead Job in UK VBeyond Europe
Global Regulatory Affairs Lead VBeyond Europe
£ -
CTAClinical TrialsCompanion DiagnosticsIn Vitro Diagnostics
Mid-level (3-4 years) - Senior (5-8 years)
UK
20+ employees
HealthcareBiotechnology PharmaceuticalsRegulatory
Role
Who you are
- 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
What the job involves
- 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
Company
Company mission
VBeyond Europe aims to advance the field of in vitro diagnostics and precision medicine by providing innovative regulatory solutions that support the development and commercialization of advanced biomarker-driven therapies and digital health technologies. The organization is dedicated to enhancing patient outcomes in various therapeutic areas through strategic regulatory leadership and collaboration.Company values
- Innovation
- Integrity
- Collaboration
- Excellence