Regulatory Submissions Manager - EMEA

Job Overview:

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

Please apply only if you are based in the listed countries.

Summary of Responsibilities:

• 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. Coordinate responses to queries ensuring required timelines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to larger 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 a backup in case of unexpected absences of other team members.
• Ensure responsible deliverables are met within required timelines 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

Qualifications (Minimum Required):

• Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations.

Experience (Minimum Required):

• Minimum of 5 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.
• Excellent communication, organization, and planning skills with an attention to detail.
• Direct supervisory and project management skills and ability to work independently.

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