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

Group 10

  • Manage Regulatory Activities in LATAM
  • Organize and coordinate the RA teams in LATAM
  • Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

Group 11
Education & Experience

  • University background and/or experience in Regulatory affairs
  • Degree in relevant life science discipline
  • 2 to 5 years of experience in Regulatory Affairs

Group 13

Hard/Technical skills:

  • Experience in line management
  • Knowledge of LATAM regulations (in Mexico, Guatemala, Panama, Dominican Republic)
  • Good understanding of regulatory tracking database software (Register), eDMS, MS Word, MS Excel

Soft skills:

  • Excellent organizational and interpersonal skills
  • Excellent coordination skills
  • Ability to work well within a team and autonomously
  • Ability to prioritize different workloads/multi-task
  • Process orientated with good attention to detail
  • Personal responsibility for ensuring a high standard of work
  • Fluency in Spanish and English

Senior Regulatory Affairs Officer 667