Fortrea
Regulatory Submissions Manager - EMEA
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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
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Oversight and Accountability:
- 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.
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Compliance and Quality Assurance:
- 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.
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Liaison and Support:
- 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.
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Project Management and Risk Management:
- 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.
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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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