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

Group 10

  • Assisting with the preparation of LATAM Marketing Authorisation Applications
  • Preparation and submission of documentation for post-authorisation activities
  • Preparation and submission of Technical/Site Transfer Applications
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Assisting with license applications as required.
  • Monitoring and maintaining up-to-date knowledge of national guidelines/legislation (in Mexico, Guatemala, Panama, Dominican Republic).
  • Ensuring compliance with the regulations of the LATAM region
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Using a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
  • Realizing general regulatory administration duties and compliance requirements
  • Ensuring the management of artwork generation

Group 11
Education & Experience

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience
  • 2 to 4 years of experience in Regulatory Affairs
  • Experience in LATAM regulations and lifecycle maintenance

Group 13

Hard/Technical skills:

  • Knowledge of LATAM regulations (Mexico, Guatemala, Panama, Dominican Republic) for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
  • Good understanding of regulatory tracking database software (Register, LorenZ, Trackwise), MS office, VeeVa (or comparable eDMS), etc
  • Fluency in Spanish
  • Good command of English to communicate with clients

Soft skills:

  • Excellent organizational and coordination skills
  • Ability to work well within a team
  • Process oriented with good attention to detail
  • Effective oral and written communication skills
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget

Regulatory Affairs Officer M/F - 714