Senior Regulatory Compliance Expert

1 semana atrás

Salvador, Brasil Bebeeregulatory Tempo inteiro

Job Overview:The Senior Regulatory Specialist role requires proactive interaction with regulatory authorities to provide guidance on requirements and maintain awareness of current regulatory standards related to submissions.This position serves as a local expert in project start-up activities for a particular country or region, acting as a knowledge resource to mentor and train new hires and less-experienced colleagues.Key Responsibilities:Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.Coordinate, collect, and organize data and information required by regulatory authorities, including preparation of study documentation.Compile and prepare routine submission files and liaise with regulatory authorities regarding submission/approval.Liaise with vendors in the generation of regulatory authority submissions.Perform review of final submission documents.E nsure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.Prevent and escalate study issues appropriately and in a timely fashion.

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