Job title:_ Regulatory Labelling_
- _ Location: México_
- _ 60% Remote working_
- _ Job type: Permanent_
About the job
Our Team:
- Coordinate labelling and packaging regulatory topics in LATAM, when impact on Share Pack._
- Coordinate and support Interns/Trainee that report to this position._
Main responsibilities:
- Labelling and packaging
- Coordinate labelling and packaging regulatory topics in LATAM, when impact on Share Pack and not under Affiliate responsibility.
- Support VISTALink 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 labelling texts/material for Shared packs, according to new reference document.
- Support countries in mitigation plans and Shared Pack activities.
- Coordination of activities in case of DL with impact on Shared Pack harmonized labelling.
- People development
- Coordinate training for LATAM Spanish speaking region on labelling 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: _Relevant experience in a similar role in Regulatory Affairs within the pharmaceutical industry. Experience working within an international company with a complex organizational environment._
- Soft skills: _Demonstrated and recognized capacity to teamwork, s_trong _interpersonal/communication_ skills. Attention to detail and problem-solving skills._
- Technical skills: _Strong knowledge in labelling changes, processes, and tools. Intermediate to advanced excel knowledge._
- Education: _Bachelor's degree in pharmacy or related field._
- Languages: _Intermediate-Advanced_ English proficiency_
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