Regulatory Compliance Specialist

hace 1 mes


Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo
Job Overview

MEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.

Key Responsibilities:

  • Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
  • Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
  • Compile and prepare routine submission files to IRB/IEC/Third body/Regulatory Authorities.
  • Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
  • Perform a review of final submission documents.
  • Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.

Requirements:

  • Strong knowledge of regulatory requirements and guidelines in the assigned countries.
  • Excellent communication and organizational skills.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office and clinical trials management systems.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.


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