Regulatory Submissions Ass Manager II

Job Overview

Collaborate with peers across the organization in order to achieve client-centric delivery in a matrix organization. In particular, collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.

• Oversight and accountability for RA IRB/EC and Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon time lines by tracking submission/approval timelines against projected milestones within relevant systems. Coordinate responses to queries and ensure the required time lines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to smaller projects in terms of size and complexity in regional and/or global role.
• Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing, and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out.
• Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC, and Third Body submissions. Evaluate the impact of clinical/regulatory changes on assigned projects as well as overall business operations.
• Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients.
• Where applicable and if suitably experienced, provide guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. 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 time lines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables.
• Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope or overburn.
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. 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).
• Contribute to the development of the group through participating in process improvement initiatives, e.g., developing and updating SOPs.
• Mentor more junior Site Readiness team members. Perform any other duties as required by the department.
• All other duties as needed or assigned.

• Recommended:
  Bachelor's Degree in Life Sciences or equivalent.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• Minimum 3 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development.
• Strong CTIS experience needed.

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