Spclst, Regulatory Affairs

hace 4 semanas

Federal, México MSD A tiempo completo

El **ESPECIALISTA DE ASUNTOS REGULATORIOS** ayudará en las actividades regulatorias de productos para dar soporte a nuestra empresa.

**Competencias**:

- Garantiza la preparación oportuna, la presentación y el seguimiento adecuado de nuevas solicitudes de Registro ante la COFEPRIS.
- Garantiza el mantenimiento de los productos asignados y autorizados mediante la presentación oportuna de prórrogas y modificaciones a las condiciones de registro sanitario.
- Para productos y actividades asignadas, se mantiene actualizado(a) sobre los proyectos de pipeline, regulaciones y otras guías. Implementa los planes de acción regulatorios ad-hoc, según sea necesario.
- Realiza los sometimientos de forma oportuna y correcta de nuevas solicitudes de Registro Sanitario asignados en estrecha cooperación con personas relevantes en los ámbitos administrativo, médico, marketing, farmacovigilancia y otros a nível regional, dependiendo del tipo de solicitud.
- Realiza el seguimiento del proceso y gestión de respuestas a prevenciones de COFEPRIS sobre registro de productos, nuevas indicaciones y otros sometimientos para lograr los mejores tiempos de aprobación.
- Garantiza la utilización correcta y adecuada del sistema de creación de artes para la implementación de artes después de aprobaciones regulatorias.
- Garantiza la implementación, el uso eficiente y consistente de bases de datos y sistemas regulatorios internos de la afiliada.
- Garantiza que los expedientes y archivos relacionados con el área se mantengan actualizados, íntegros y completos.
- Participa en el establecimiento y mantenimiento de Procedimientos Normalizados de Operación relevantes para asegurar que se cumpla la regulación y procesos corporativos vigentes.

**Habilidades de Liderazgo**:

- Demostrar convicción, proactividad y perseverancia al influir en otros y superar resistencias; Obtiene apoyo de sus perspectivas e ideas propias al establecer vínculos claros y positivos entre sus ideas y las necesidades del negocio.
- Fuertes competencias de comunicación.

**Requisitos de Educación y Experiência**:

- Título universitario/licenciatura o equivalente en farmacia, química o disciplinas equivalentes/similares.
- 3 años de experiência en asuntos regulatorios. Puede ser una persona con experiência y/o capacitación relacionada o una combinación equivalente de educación y experiência en asuntos regulatorios y/o calidad.

**Secondary** Language(s) Job Description**:
The **REGULATORY AFFAIRS SPECIALIST** will assist in product regulatory activities to support and maintain our products commercialization.
- For assigned products and tasks, stays updated on late our company pipeline filings, relevant local regulations, and guidelines. Implements regulatory ad-hoc local action plans, as necessary.
- Tracks process and manages answers to queries from the Agency on products registration, new indications, and other submission to achieve best approval timelines.
- Implements local action plans for new products.
- Ensures the correct and proper utilization of artwork system to generate artwork and to implement revisions to artworks.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems of the affiliate.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations and company processes are complied with.

**Leadership Skills**:

- Demonstrate conviction, proactivity, and persistence when influencing others and overcoming resistance; gains support for one's perspectives and ideas by establishing clear, positive links between ideas and business needs.
- Strong communication competencies.

**Education & Experience Requirements**:

- University/bachelor's Degree or Equivalent within pharmacy, chemistry, or equivalent/similar disciplines.
- 3 years of related experience in regulatory affairs. Can be a person with related experience and/or training or an equivalent combination of education and experience in regulatory affairs and/or quality.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R283695

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