Regulatory Affairs Specialist

{"h1": "Join Galderma's Regulatory Affairs Team", "p": "At Galderma, we are committed to advancing dermatology for every skin story. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our innovative products and services.

Your key responsibilities will include:

* Implementing regulatory affairs programs and policies to support product regulatory activities, including biologicals, chemical drugs, medical devices, and cosmetics.
* Assisting in writing and editing manuscripts on clinical studies and scientific reports for submission to regulatory agencies or for in-company use.
* Tracking product safety and ensuring compliance with legislation and regulations.
* Preparing and reviewing regulatory compliance documents, including literature for new products and revising existing literature.

We are looking for a highly motivated and detail-oriented individual with a strong background in regulatory affairs, preferably in the pharmaceutical, cosmetic, or medical device industry.

If you are passionate about doing something meaningful for consumers, patients, and healthcare professionals, and have a strong vision for the future of dermatology, we encourage you to apply.

**Key Requirements:**

* Master's or Bachelor's degree in a relevant field
* Minimum 4 years of experience in regulatory affairs
* Strong knowledge of legislation and regulations in the region
* Excellent communication and teamwork skills

**What We Offer:**

* A dynamic and supportive work environment
* Opportunities for professional growth and development
* A competitive salary and benefits package

**Location:**

Bogotá

**Core Mission:**

Implement regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific and medical writing on both new and in-line products, in accordance with health authorities.

**Responsibilities:**

* 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 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.

**Location:**

Bogotá

**Core Mission:**

Implement regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific and medical writing on both new and in-line products, in accordance with health authorities.

**Responsibilities:**

* 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 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.

**Location:**

Bogotá

**Core Mission:**

Implement regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific and medical writing on both new and in-line products, in accordance with health authorities.

**Responsibilities:**

* 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 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.

**Location:**

Bogotá

**Core Mission:**

Implement regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific and medical writing on both new and in-line products, in accordance with health authorities.

**Responsibilities:**

* 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 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 doesn

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