Regulatory Affairs Coordinator

Encontrado en: beBee S CO - hace 4 semanas

Bogotá, Colombia GALDERMA A tiempo completo

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

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: Mini 4 años de experiencia en Asuntos Regulatorios, reciente, idealmente en Perú, Ecuador, Bolivia, Venezuela, Cono Sur

Experiencia en la industria farmacéutica, cosmética y/o de dispositivos médicos

  • Estándares éticos muy altos
  • Conocimiento de la legislación de medicamentos, cosméticos y dispositivos médicos en Perú, Ecuador, Bolivia, Venezuela, Cono Sur
  • Trabajo en equipo
  • Visión estratégica
  • Trabajo autónomo

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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