Regulatory Affairs Manager (M/F/D)

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 timelines by tracking submission/approval timelines against projected milestones within relevant systems. 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 product. 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. 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. 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. 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. 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). Bachelor's Degree in Life Sciences or equivalent. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) ~ Minimum 4 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development. Office environment. Global travel required 5% of the time, which will require an overnight stay. Travel is primarily to Europe/US. Learn more about our EEO & Accommodations request here. .