Regulatory Submissions Associate Manager I - EMEA

This a Full Remote job, the offer is available from: Africa, EMEA Summary of Responsibilities: • Coordinates and oversees Regulatory Authority, Ethics Committee/Institutional Review Board, Third Body submissions for all study types across multiple countries globally including EU CTR through CTIS platform. • Develops submission strategies, timelines, and progress updates in collaboration with Start‑Up Lead and Client regulatory teams. • Contributes to Start-Up project plans, ensuring compliance across Regulatory Authority, Ethics Committee/Institutional Review Board, Third Body submission activities and proactively escalating risks to timelines, budget, and scope • Manages compilation and release of core submission documents, including cover letters, application forms, and letters of authorization. • Oversees the work of Site Readiness & Regulatory Specialists (SRRS) and sub‑CROs, ensuring accurate preparation, QC, and delivery of country submission packages throughout the study lifecycle supporting responses to questions, amendments, modifications, notifications, and study closure activities. • Provides expert regulatory guidance throughout the study lifecycle by maintaining up-to-date knowledge of relevant legislation and assessing the impact of regulatory or clinical changes on assigned projects. • Oversees submission and approval milestone tracking, eTMF, country and regional clinical study registry entries. • Builds strong relationships with regulatory bodies and sponsor counterparts, using strategic thinking and problem‑solving to navigate regulatory challenges. Qualifications (Minimum Required): • Bachelor's Degree in Life Sciences or equivalent • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. • Language Skills Required: Fluent English Experience (Minimum Required): • Minimum 3 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development. Learn more about our EEO & Accommodations request here. This offer from "Fortrea" has been enriched by Jobgether.com and got a 77% flex score. Apply tot his job Apply tot his job Apply To this Job