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Innovation
Consulting

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico.

Group 10
Responsibilities

  • Assisting with the preparation of LATAM Marketing Authorization Applications
  • Preparation and submission of documentation for post-authorization activities
  • Compile Dossier as per country requirements

Group 11
Education & Experience

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience
  • 0 to 2 years of experience in Regulatory Affairs

Group 13
Profile

Hard/Technical skills:

  • Knowledge of LATAM regulations (Mexico, Guatemala, Panama, Dominican Republic) for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
  • Aware of Module 1 to 3 requirements
  • System management & knowledge of RA Tools
  • Fluency in Spanish
  • Fluent English language to communicate with clients
  • Portuguese desirable but not essential

Soft skills:

  • Client Oriented
  • Good IT skills/knowledge
  • Good organizational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Associate M/F - 845

Apply