Regulatory Submissions Associate Manager I EMEA

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 StartUp 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 subCROs 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 problemsolving to navigate regulatory challenges.

Qualifications (Minimum Required):

Bachelors 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.

Required Experience:

Manager

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 ...