Regulatory Affairs Coordinator Latam

hace 2 meses

Bogotá Cundinamarca, Colombia Galderma A tiempo completo

Con un legado único en dermatología y décadas de innovación de vanguardia, Galderma es el líder emergente en la categoría de dermatología, presente en aproximadamente 90 países. Ofrecemos un portafolio innovador basado en la ciencia de marcas emblemáticas premium y servicios que abarcan todo el espectro del mercado de la dermatología en rápido crecimiento a través de Estética Inyectable, Cuidado Dermatológico y Dermatología Terapéutica. Desde nuestra fundación en 1981, hemos dedicado nuestra atención y pasión al órgano más grande del cuerpo humano, la piel, satisfaciendo las necesidades individuales de consumidores y pacientes con resultados superiores en asociación con profesionales de la salud. Porque entendemos que la piel en la que vivimos moldea nuestras vidas, estamos avanzando en dermatología para cada historia de piel.

Buscamos personas que se centren en obtener resultados, abracen el aprendizaje y traigan una energía positiva. Deben combinar la iniciativa con un sentido de trabajo en equipo y colaboración. Sobre todo, deben estar apasionados por hacer algo significativo para los consumidores, pacientes y profesionales de la salud a quienes servimos todos los días. Nuestro objetivo es empoderar a cada empleado y promover su crecimiento personal mientras se asegura de que se satisfagan las necesidades comerciales ahora y en el futuro. En toda nuestra empresa, valoramos la diversidad y respetamos la dignidad, la privacidad y los derechos personales de cada empleado.

En Galderma, damos activamente a nuestros equipos razones para creer en nuestra ambiciosa meta de convertirnos en la principal empresa de dermatología del mundo. Con nosotros, tienes la oportunidad definitiva de adquirir nuevas y desafiantes experiências laborales y crear un impacto directo sin igual.

Location: Bogotá

Core Mission: Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to product regulatory (Biologicals, chemical drugs, medical devices and comsetics), Drugs CMC regulatory, Regulatory operations and Scientific & Medical writing on both new and in-line products, in accordance with health authorities.

Responsibilitites:

- Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to product regulatory (Biologicals, chemical drugs, medical devices and cosmetics), Drugs CMC regulatory, Regulatory operations and Scientific & Medical writing on both new and in-line products, in accordance with health authorities
- Implement Regulatory Affairs programs and policies for preparation, submission and follow-up of medical affairs and authorities (MAA) and archive registration files
- Assist in writing and editing manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication
- Track product safety and fulfil the regulatory requirements compliant with legislation and regulations pertaining to the business
- Implement Regulatory Affairs plans and processes for all activities related to Regulatory reporting/documentation for internal and external audiences; Gathering data, preparing, reviewing, and/or approving regulatory compliance documents; Compiling, analyzing, and summarizing additional data from other sources as needed
- Assist in preparing literature for new products and revising existing literature and writing and maintaining files on informative journal abstracts according to current or estimated future needs

Requirements:
Education/Training: Master's / Bachelor’s Degree or equivalent experience/qualification

Experience: Minimum 5 years of recent experience in Regulatory Affairs, ideally in Ecuador, Peru, Venezuela, Bolivia or Southern Cone Experience in the pharmaceutical, cosmetic and/or medical device industry Very high ethical standards Knowledge of the legislation of medicines, cosmetics and medical devices in Ecuador, Peru, Venezuela, Bolivia or Southern Cone Knowledge of advertising of both product categories. Teamwork, Strategic visión, Autonomy

Employer’s Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

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