Reg Submissions Ass Manager (China)

Shanghai, ChinaOn-site

Responsibilities

Coordinate responses to queries and ensure the required timelines are met.
Evaluate the impact of clinical/regulatory changes on assigned product.
Manage applicable user access to CTIS and act as back up in case of unexpected absences of other team members.
Review and input into required Start Up project plans.
Distribute, implement, and monitor compliance to a Start Up project plan with respect to RA, IRB/EC, and Third Body submissions.
Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones.
Manage projects according to the billing guide to ensure the work is performed within budget.
Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects.
Support audits (internal and external) and inspections, as needed.
Support resolution of any findings.
Present/attend at external and internal meetings including, but not limited to project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM).
Mentor more junior Site Readiness team members.
Perform any other duties as required by the department.
Oversight and accountability for RA, IRB/EC, and Third Body submissions, including submission strategy, timeline, planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems.

Qualifications (Minimum Required): Bachelor’s Degree in Life Sciences or equivalent. Fortrea may consider relevant and equivalent
experience in lieu of educational requirements.
experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development.

Job Overview: Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization.