Regulatory Submissions Associate Manager I - 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.
Apply Now
Apply Now
• 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.
Apply Now
Apply Now