Main activities:
...regulatory affairs coordinator.
- montevideo, montevideo
- publicado hoy
- finaliza el 2 julio 2026
detalles del trabajo
resumen
- montevideo, montevideo
- tiempo completo
- reference number2820
detalles del trabajo
- Develop and communicate regulatory expectations to both internal andexternal stakeholders.
- Create strategies and conduct risk assessments to ensure that submissiontimelines align with applicable regulations.
- Prepare and assemble regulatory submission dossiers for local authorities.
- Collaborate with global, local, and regional teams to ensure submissions arecomprehensive andcompliant.
- Maintain systems updated (Veeva, among others)
- Analyze and review local regulations to identify potential risks andopportunities.
- Implement strategies to mitigate risks and leverage opportunities based onregulatory changes.
- Regularly interact with managers regarding activities, issues, and milestones.
- Build and maintain relationships with third parties and cross-functionalstakeholders to enhance performance and resolve critical issues in submissionprocesses.
- Review and approve labeling, artwork, mockups, and promotional materialmaterials to ensure compliance with regulations.
- Support the planning, coordination, and preparation of all necessarydocuments for health authority submissions in the LATAM region.
- Represent the LATAM region in global forums for specific products or projects.
- Maintain fluent communication with internal customers to achievedepartmental performance goals.
- Promotional materials reviews and approvals according to LatAm regulations.
- Interacts closely with the regulatory Liaison; participates intrainings to enhance knowledge of regulatory environment to ensurecomplete products submissions.
Qualifications:
- Bachelor’s degree in pharmaceutical chemistry, Biochemical chemist or otherScience degreepreferred, with minimum of 4years of experience as aregulatory professional.
- Experience with and knowledge of the regulatory environment in LatAmcountries, especially Paraguay, is required.
- Excellent verbal and written communications skills, both in English.
- Effectively prioritizes competing tasks in a fast-paced and dynamicenvironment.
- Ability to interact effectively with all levels of management.
- Effective time management and prioritization skills to manage severalinitiatives with demonstrated ability to achieve success.
- Proficiency in use of databases, excel, power point.
Sobre Randstad
En Randstad, conectamos a las personas con oportunidades laborales que transforman vidas. Combinamos nuestra pasión por el talento humano con tecnología innovadora para crear experiencias que impulsen el éxito en el empleo. Nos esforzamos todos los días en crear entornos de trabajo diversos e inclusivos y nos enorgullece ser una empresa con igualdad de oportunidades para todas las personas.
En el marco de la Ley 19.691 el llamado comprende a candidatos que estén inscriptos en el Registro Nacional de Personas con Discapacidad que funciona en el Ministerio de Desarrollo Social.
Somos tu socio en la búsqueda de trabajo.
Somos Partner for Talent.
Main activities:
...- Develop and communicate regulatory expectations to both internal andexternal stakeholders.
- Create strategies and conduct risk assessments to ensure that submissiontimelines align with applicable regulations.
- Prepare and assemble regulatory submission dossiers for local authorities.
- Collaborate with global, local, and regional teams to ensure submissions arecomprehensive andcompliant.
- Maintain systems updated (Veeva, among others)
- Analyze and review local regulations to identify potential risks andopportunities.
- Implement strategies to mitigate risks and leverage opportunities based onregulatory changes.
- Regularly interact with managers regarding activities, issues, and milestones.
- Build and maintain relationships with third parties and cross-functionalstakeholders to enhance performance and resolve critical issues in submissionprocesses.
- Review and approve labeling, artwork, mockups, and promotional materialmaterials to ensure compliance with regulations.
- Support the planning, coordination, and preparation of all necessarydocuments for health authority submissions in the LATAM region.
- Represent the LATAM region in global forums for specific products or projects.
- Maintain fluent communication with internal customers to achievedepartmental performance goals.
- Promotional materials reviews and approvals according to LatAm regulations.
- Interacts closely with the regulatory Liaison; participates intrainings to enhance knowledge of regulatory environment to ensurecomplete products submissions.
Qualifications:
- Bachelor’s degree in pharmaceutical chemistry, Biochemical chemist or otherScience degreepreferred, with minimum of 4years of experience as aregulatory professional.
- Experience with and knowledge of the regulatory environment in LatAmcountries, especially Paraguay, is required.
- Excellent verbal and written communications skills, both in English.
- Effectively prioritizes competing tasks in a fast-paced and dynamicenvironment.
- Ability to interact effectively with all levels of management.
- Effective time management and prioritization skills to manage severalinitiatives with demonstrated ability to achieve success.
- Proficiency in use of databases, excel, power point.
Sobre Randstad
En Randstad, conectamos a las personas con oportunidades laborales que transforman vidas. Combinamos nuestra pasión por el talento humano con tecnología innovadora para crear experiencias que impulsen el éxito en el empleo. Nos esforzamos todos los días en crear entornos de trabajo diversos e inclusivos y nos enorgullece ser una empresa con igualdad de oportunidades para todas las personas.
En el marco de la Ley 19.691 el llamado comprende a candidatos que estén inscriptos en el Registro Nacional de Personas con Discapacidad que funciona en el Ministerio de Desarrollo Social.
Somos tu socio en la búsqueda de trabajo.
Somos Partner for Talent.
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