Senior Regulatory Affairs Consultant (IVDR) in Bucuresti

A Regulatory Affairs Senior Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting (PC) provides. A Regulatory Affairs Senior Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Senior Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Regulatory Affairs SC assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.We are currently looking for a Regulatory Affairs Senior Consultant who will have the following responsibilities: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.QualificationsIdeal 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.