Regulatory Labeling

Job title: Regulatory Labeling Analyst

• Location: Mexico City
• Job type: Permanent, Full time

About the job

Main responsibilities:

Coordinate labeling and packaging regulatory topics in LATAM, when impact on Share Pack and support Interns/Trainee that report to this position.

Labeling and packaging

• Coordinate labeling and packaging regulatory topics in LATAM, when impact on Share Pack and not under Affiliate responsibility.
• Support VISTALink/OnePack regulatory activities in LATAM for Shared Packs.
• CP2 activities for deferred action countries and include Planned submission date in Veeva Vault for Shared Packs.
• Definition together with affiliate of submission strategy for deferred countries and Shared Packs.
• Coordinate update/update labeling texts/material for Shared packs, according to new reference document, local requirements and aligned strategy.
• Support countries in mitigation plans and Shared Pack activities.
• Coordination of activities in case of DL with impact on Shared Pack harmonized labeling.

People development

• Coordinate training for LATAM Spanish speaking region on labeling process.
• Support activities conducted by other analysts and interns and service providers.

Process improvement:

• Optimization of workflows and work tools for continuous improvement.

About you

• Experience:
  • Strong knowledge of labeling changes, processes and tools.
  • Experience working within an international company with a complex organizational environment.
• Soft skills:
  • Demonstrated and recognized capacity to teamwork.
  • Strong interpersonal/communication/negotiation skills.
• Technical skills:
  • Intermediate to advanced excel knowledge.
• Education:
  • Heath Care Graduation (HCP), chemists, physicians, biologists, pharmacists.
  • Relevant experience in similar position.
• Languages:
  • Good/Intermediate level of spoken and written English and Spanish.

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