Strategic Regulatory Expert for Clinical Trials

hace 24 horas


Xico, México Glaxosmithkline A tiempo completo

GSK seeks a highly skilled Strategic Regulatory Expert to lead the set-up and execution of regulatory strategies for clinical trials across all therapeutic areas. As a key member of our team, you will be responsible for providing support in achieving the Study Start-up process.

Responsibilities:

  • Coordinate planning, start-up, and maintenance of regulatory operational activities involved in clinical studies
  • Apply deep technical expertise and understanding of local regulatory environment to drive delivery of business objectives
  • Work closely with local teams to ensure accurate planning, prioritization, anticipation, and mitigation of risks
  • Prepare and review documentation required for regulatory processes (e.g., ethics, research, and biosafety committees, Ministry of health)
  • Stay up-to-date with changes in regulations or submission requirements
  • Coordinate with study and site related processes (e.g., handling regulatory queries)

Requirements:

  • Bachelor's degree or equivalent
  • Broad experience in clinical trial applications of clinical trials to Cofepris
  • Strong written and verbal communications skills in English and Spanish
  • Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment
  • Deep knowledge of Mexican regulations for clinical research

Salary Range: $80,000 - $120,000 per year

About GSK: We unite science, technology, and talent to get ahead of disease together. As a global biopharma company, we focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.



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