Director Global Regulatory Strategy In Vitro Diagnostics

Company: AgHires
Location: Hanover
Posted on: April 11, 2021

Job Description:

The primary responsibilities of this role, Director Global Regulatory Strategy In Vitro Diagnostic, are to:

• Develop regulatory strategy for assigned In Vitro Diagnostic projects (IVD) by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the global regulatory plan);
• Ensure global regulatory plans support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies;
• Be involved actively in decision making on all key development questions via an assessment on the probability of IVD regulatory success;
• Develop the regional/global regulatory project goals from development through life cycle management;
• Represent global regulatory affairs on assigned global IVD Project teams;
• Develop submission materials for local and global IVD submission, guide the review process, check for accuracy, scientific consistency, compliance to local and global in vitro diagnostics regulations and completeness of IVD submission;
• Lead a Global Regulatory Team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned IVD projects;
• Organize and drive preparations for meetings and teleconferences with local and global IVD HA officials;
• Conduct regulatory IVD due diligence on potential partnership opportunities. Sign Up for Job Alerts & AgHires Email Newsletter By clicking this button, you consent to receive emails about new jobs that relate to your search criteria. Remember: you can cancel these email alerts at any time.

Keywords: AgHires, Boston , Director Global Regulatory Strategy In Vitro Diagnostics, Executive , Hanover, Massachusetts