Regulatory Affairs Specialist

hace 6 días


Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.

Key responsibilities include:

  • Providing regulatory advice and carrying out projects in the provision of regulatory affairs services.
  • Acting as liaison with internal stakeholders in the provision of these services.
  • Working with the Regulatory Affairs Management to perform the day-to-day operational aspects of the Department, such as assessment of regulatory documents, preparation and assembly of global regulatory submissions, and QC review of the final submission package.
  • Interfacing with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
  • Developing and maintaining a cooperative working relationship with Project Managers and project team members for assigned projects.
  • Advising and directing project team as to their responsibilities relative to regulatory strategy/submission activities.
  • Acting as a key liaison between Regulatory Affairs Department and project team for assigned projects.

Requirements include:

  • Bachelor's Degree; degree in Pharmacy or Life Science is an advantage.
  • Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered.
  • Some regulatory affairs experience is preferable but not mandatory.
  • An appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset.
  • Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.
  • Excellent English language communication skills, both verbal and in writing.
  • Computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage.
  • Good organizational and planning skills. Ability for multiple project tasking.
  • Proven ability to work effectively in a team, including in a multinational one.
  • Problem solving skills and strong attention to detail.


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