My client is a global CRO company who operate in over 20 countries. They specialise in various therapeutic areas, a few being rare diseases and gene therapy. They are currently seeking a Director, Regulatory Affairs based in North Carolina to join their dynamic team!
The Director, Regulatory Affairs is responsible for developing, implementing, and leading both regional and international strategy for assigned projects with various cross-functional teams and senior level client collaborations. In this role, you will oversee the execution of regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development and post approval and address the analysis and evaluation of regulatory procedures and changes to ensure attainment of corporate goals.
This role provides guidance for, and actively contributes to, the development of documents for regulatory agencies, such as Investigational New Drug applications (INDs)/Investigational Medicinal Product Dossiers (IMPDs)/Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)/Biologics License Applications (BLAs)/Marketing Authorization applications (MAAs), ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. As a Director, Regulatory Affairs, you will supervise/manage others within the Regulatory Affairs skill group.
What You'll Need
- Bachelor’s degree, or international equivalent from an accredited institution, in science or health related field; PhD preferred
- 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience
- 8-9 years progressive regulatory affairs experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company
- 6-7 years supervisory/management experience
- Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything