Associate I, Regulatory Operations

Alcon MX; Aguascalientes; Presencial; MXN 240.000 - 360.000; Jornada completa

Descripción de la vacante

Alcon MX busca iniciar una trayectoria profesional en Regulatory Operations, dentro de su función de Calidad y Régimen Regulatorio. La persona seleccionada apoyará objetivos de proyecto manejando presentaciones regulatorias, manteniendo bases de datos y asegurando el cumplimiento de normativas externas e internas, con especial atención a dossiers, licencias y etiquetado.

El rol requiere experiencia relevante, conocimiento de GxP y SOP, y la habilidad de interpretar regulaciones para asesorar a

Formación

• Se requiere educación y experiencia relevantes para realizar las responsabilidades del rol.
• Conocimiento de buenas prácticas regulatorias (GxP) y procedimientos SOP.
• Capacidad de interpretar regulaciones y asesorar a la dirección.

Responsabilidades

• Apoyar presentaciones regulatorias, manteniendo bases de datos y cumplimiento de normativas.
• Elaborar expedientes y gestionar presentaciones para todas las franquicias.
• Publicación de presentaciones, licencias y etiquetado conforme a regulaciones.
• Mantener archivos de Regulatory Affairs y administración de Tech File.
• Garantizar que los productos cumplan con regulaciones externas e internas.

Descripción del empleo

Resumen de descripción de puesto

The Regulatory Operations job family involves roles responsible for handling the operational "back-office" aspects of regulatory submissions, such as dossier preparation, Clinical Trial Disclosure, submission management for all franchises, Submission publishing, licensing, and labeling. Professionals in this family ensure timely and accurate submission of regulatory documents and maintain up-to-date databases of submissions and approvals. Maintenance of Regulatory Affairs Archives and Tech File Administration.

Descripción de puesto

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Associate I, Regulatory Operations (Professional Path) is primarily responsible for supporting project goals by handling regulatory submissions, maintaining databases, and ensuring compliance with external regulations. You will prepare dossiers, manage submissions, and maintain Regulatory Affairs Archives. Specifics Include:

• Apply specialized knowledge to perform tasks and achieve objectives
• Handle operational aspects of regulatory submissions, ensuring timely and accurate submission of documents
• Maintain up-to‑date databases of submissions and approvals
• Prepare dossiers, manage submissions for all franchises, and oversee submission publishing, licensing, and labeling
• Maintain Regulatory Affairs Archives and Tech File Administration
• Follow procedures with decision‑making authority, requiring job‑related training, attention to detail, and reliability
• Ensure products comply with external regulations, internal standards, and customer requirements
• File product notifications, approval applications, and quality testing results with government and regulatory agencies
• Interpret proposed regulations and advise management on their impact
• Implement and audit compliance processes
• Provide guidance to development and marketing teams on product changes, quality testing, labeling, literature, and advertising
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Meet individual job requirements and contribute to overall compliance of the organization
• Commit to continuous improvement in operations

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Qualifications

Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well‑known Opti‑Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.