Global Regulatory Expert

Há 2 dias

Salvador, Bahia, Brasil beBeeRegulatory Tempo inteiro R$63.000 - R$97.800
Job Overview

The Senior Regulatory Specialist serves as the primary point of contact for investigative sites during site start-up activities and maintenance, ensuring timely delivery of high-quality results.

  • Maintain awareness of regulatory legislation, guidance, and best practices in assigned countries.
  • Coordinate collection and organization of data and information required by EC/IRB/Third body/Regulatory Authority, optimizing data management processes.
  • Liaise with internal and external vendors to generate high-quality Regulatory Authority submissions, driving business success.
  • Perform thorough review of final submission documents, ensuring accuracy and compliance.
Responsibilities

The Senior Regulatory Specialist will:

  • Ensure all assigned start-up and maintenance activities are on track, meeting client expectations and fostering a positive working relationship.
  • Prevent and escalate study issues promptly and efficiently, minimizing delays and disruptions.
  • Serve as a local expert in project start-up activities for a particular country or region, providing valuable insights and guidance.
  • Act as a 'knowledge resource' to mentor and train new hires and less-experienced department colleagues, promoting professional growth and development.
Clinical Trials Information System (CTIS) Tasks

The Senior Regulatory Specialist will assist in uploading submission documentation to CTIS, interacting with and monitoring notifications and alerts to ensure milestones and events for the trial are met within timelines mandated.

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