Regulatory Affairs Senior Analyst

hace 2 semanas


Buenos Aires, Argentina Kenvue A tiempo completo

Regulatory Affairs Senior Analyst W

Description

  • En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad._
  • La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y consumidores todos los días durante más de 130 años. Independientemente de su raza, creencia, orientación sexual, religión o cualquier otro rasgo, TÚ eres bienvenido en todos los puestos vacantes en la compañía de cuidado de la salud más grande del mundo._
  • Cuando te unes a Johnson & Johnson, tu movimiento podría significar nuestro próximo avance._
  • El 12 de noviembre de 2021, Johnson & Johnson anunció los planes de separar nuestro negocio de Consumer Health y crear una nueva empresa que cotice en bolsa. Se planea que el proceso de separación se complete en un plazo de 24 meses y estará sujeto a requisitos legales, incluyendo la consulta con los comités laborales y otros órganos que representen a los empleados, según sea necesario, y otras condiciones y aprobaciones habituales. Si acepta este puesto, se espera que, después del cierre de la transacción, sería un empleado de una nueva entidad dentro de "New Consumer Health" y su vinculación se regirá por los procesos de empleo, programas, políticas y planes de beneficios de "New Consumer Health". En ese caso, "New Consumer Health" le proporcionará detalles de cualquier cambio en el momento apropiado y sujeto a los procesos de consulta necesarios._

_Descripción del puesto:
_


_Johnson & Johnson New Planned Consumer Health Company__ _está reclutando un Regulatory Affairs Senior Analyst. Esta posición está basada en Buenos Aires, Argentina, y tiene un alcance Regional. Sus responsabilidades incluyen el manejo de proyectos de innovación de un amplio portafolio de productos, interacción con Autoridades Sanitarias, supervisión de gestores y ocasional representación de la Compañía en Cámaras._

_Principales responsabilidades:
_

- _Participación y entrega para que el equipo de RA alcance metas y atienda estrategias comunes del negocio dentro del marco normativo vigente_
- _Prepara expedientes de registro comunes para la introducción de nuevos productos, desarrollo de nuevos productos, cambios de productos y renovaciones_
- _Revisa y evalúa la documentación para asegurar una interpretación precisa de las regulaciones del país_
- _Supervisar y analizar los requisitos del país para identificar tendencias/cambios en la regulación_
- _Consulta con otras partes interesadas dentro de la organización con respecto a los requisitos y estándares de presentación para facilitar el procesamiento eficiente por parte de las autoridades sanitarias en varios países_
- _Integra y ejecuta estrategias de Asuntos Regulatorios orientadas a resultados. Responsable del logro de las metas y objetivos comerciales, en función de las prioridades y considerando los beneficios/riesgos_
- _Maneja constantemente grandes cantidades de información cambiante, sofisticada y/o ambigua de productos_
- _Asiste en el desarrollo de las mejores prácticas para los procesos de Asuntos Regulatorios_
- _Apoya las implementaciones de evaluaciones de cambios mediante la planificación de cronogramas para entregables regulatorios, supervisando las presentaciones hasta su finalización_
- _Coordina información sobre varios proyectos simultáneamente_
- _Vela por el cumplimiento de las normas e interpretaciones gubernamentales_
- _Puede administrar a un Asistente Regulatorio (Pasante/Trainee) y brindar apoyo y orientación_
- _Representa Asuntos Regulatorios en equipos de productos/proyectos de funciones cruzadas y brinda asesoramiento regulatorio_
- _Participa en equipos para desarrollar conocimiento y conciencia organizacional y comprender el contexto comercial en el que se toman las decisiones_
- _Inicia la comunicación y emplea habilidades de influencia para establecer relaciones con contactos clave internos / externos_

Qualifications
- _Preparación Académica: Título universitario en Ciencias de la Salud o equivalente_
- _Experiência mínima de 2 años en posiciones de Asuntos Regulatorios de Medicamentos_
- _Nível de inglés intermedio, portugués (deseable)_
- _Ser capaz de trabajar en un ambiente dinámico, colaborativo _
- _Habilidades interpersonales para conectar con equipos multiculturales_

Primary Location Latin America-Argentina-Buenos Aires

Organization Johnson & Johnson de Argentina S.A.C. e. I.

Job Function Regulatory Affairs

  • Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives**In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...


  • Buenos Aires, Argentina ABBVIE A tiempo completo

    PURPOSE STATEMENT The mission of the Regulatory Affairs Analyst is to cooperate with the Regulatory team in several activities related to the area. The primary goals are in providing support in registration of products for Oncology and new Specialty portfolio, labeling for Region South and the activities required to release product to the Argentinean...

  • Regulatory Affairs

    hace 1 semana


    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...


  • Capital Federal, Buenos Aires, Argentina Abbott Laboratories A tiempo completo

    **Regulatory Affairs Specialist** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **The Opportunity** This position is sited in **Retiro **(Edificio Laminar) in our **Diagnostics Division**:...

  • Regulatory Affairs

    hace 2 semanas


    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Amgen A tiempo completo

    Career Category Regulatory **Job Description**: Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Introduction/Purpose The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Buenos Aires, Argentina Amgen A tiempo completo

    Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a...


  • Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • Buenos Aires, Argentina Amgen A tiempo completo

    Sr. Associate Regulatory AffairsEnsure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a...


  • Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    Regulatory Affairs Coordinator - Argentina: Work mode: Hybrid Onsite Location(s): Buenos Aires, ArgentinaAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...


  • Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **Regulatory Affairs Coordinator - Argentina**: - Work mode: Hybrid- Onsite Location(s): Buenos Aires, Argentina**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse...


  • Buenos Aires, Argentina Bioceres Crop Solutions A tiempo completo

    We are looking for a Regulatory Affairs Manager to join our Bioceres Crop Solutions teamThe mission of the position is to give support and execute Bioceres regulatory strategy for biotechnological traits and products on target crops, in order to obtain and maintain regulatory approvals in all relevant locations at a timely manner.Be the primary interface of...


  • Buenos Aires, Argentina Coca-Cola A tiempo completo

    Are you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry? We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities. If this sounds like you, this role could...


  • Buenos Aires, Buenos Aires C.F., Argentina The Coca-Cola Company A tiempo completo

    Are you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry?We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities. If this sounds like you, this role could be...