Senior/Regulatory Consultant IVDR
Attractive salary + package
A Regulatory Affairs Senior Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
- Study Risk Determinations
- Regulatory strategy assessments for diagnostic partnerships, commercial launches
- Regulatory strategy for biomarkers in clinical studies
- Leadership of engagements with FDA and other regulators as required to confirm acceptability of regulatory strategy
- Collaboration with diagnostic partners to facilitate Dx labels, regulator questions, etc.
- Communication of regulatory strategies and risks via team meetings, written communications, etc.
Ideal candidate will possess:
- BA/BS in scientific or technical discipline or advanced degree
- Companion Diagnostic regulatory experience (either Dx or pharma side)
- IVD regulatory experience, including understanding of IVDR (EU)
- Understanding of CAP/CLIA and Laboratory Developed Tests (US)
- Preferred: knowledge of international regulations for IVDs, including China and Australia
- Project management skills
- Fluent English