Regulatory Affairs Coordinator - Distributor Markets

Detalles de la oferta

Regulatory Affairs Coordinator - Distributor markets 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 cosmetics), Drugs CMC regulatory, Regulatory operations and Scientific & Medical writing on both new and in-line products, in accordance with health authorities. Responsibilities: 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 fulfill 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 4 years of experience in Regulatory Affairs, ideally in Peru, Ecuador, Bolivia, Venezuela, Cono Sur. Experience in the pharmaceutical, cosmetic, and/or medical device industry. High ethical standards. Knowledge of legislation regarding drugs, cosmetics, and medical devices in Peru, Ecuador, Bolivia, Venezuela, Cono Sur. Teamwork. Strategic vision. Ability to work independently. 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. #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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