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Date Added: YESTERDAY

Senior Regulatory Affairs Consultant (IVDR)

Romania, Romania
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Company: PAREXEL

Job Type: Permanent, FullTime

Job Description

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.
  • Qualifications

    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.
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.
    Apply Now