Premier Research is looking for a Regulatory Submissions Lead II to join our Global SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Develops the Regulatory & start-up submission project plan. Drives CA, CEC/CIRB and LEC/LIRB submission as well other boards/evaluating bodies, import and export licenses, for newly awarded studies containing countries from the same or multi-region and may take complex studies such as GMO, IP-device combo studies under supervision, or maintenance studies independently.

• Coordinates and strategically plans all required initial study submissions, as well as for the submission of the changes (substantial and non-substantial) occurred during the lifecycle of clinical study as required.

• Functions as the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and adherence to timelines and deliverables. Identifies & communicates risks and contingency plans related to SSU activities to clients and project teams. Escalates problems and provides suggestions for resolution.

• For EU interventional clinical studies, responsible for the strategic planning, coordination and actual submission via Clinical Trial Information System (CTIS) in collaboration with Sponsor and SSUAs as defined in company procedures.

• May participate in the review of the Investigational Medicinal Product Dossier (IMPD), IMP labels, protocol, etc. in conjunction with other Subject Matter Experts

• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.

 

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status