Regulatory Affairs Analyst

hace 7 meses

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 : Bogota, Colombia.

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

Responsabilities : 
• Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to product regulatory (Biologicals, chemical drugs and medical devices), 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
• 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
Carry out the operation for Regulatory Affairs area in the assigned countries
Ensure the timely delivery of all information related to the management of regulatory procedures that, in accordance with the law, must be sent to the HA of each of the assigned countries

Differentiator :
Professional who applies advanced knowledge typically obtained through advanced education and work experience
Contributes to process design and improvement

Profile : 

Minimun 3 years in regulatory affairs

Bachelor’s Degree (Pharmaceutical chemistry)

Intermediate - Advanced English level.

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.

  • Regulatory Affairs Operations Analyst

    hace 4 meses

    Bogotá, Cundinamarca, Colombia Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Dolex, Coega, Today and Centrum - through a unique combination of deep human understanding and...

  • Senior Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Colombia Buscojobs Colombia A tiempo completo

    Regulatory Affairs Coordinator Latam - Distributor Markets Location: Bogotá Core Mission: Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to products in the Latin American distributor markets. Job Responsibilities: Participate in the planning of Regulatory strategies for product submissions. ...

  • Dermatology Regulatory Affairs Specialist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Galderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join its team. This role is ideal for individuals passionate about advancing dermatology and making a meaningful impact on consumers' lives.In this position, you will be responsible for implementing regulatory programs, processes, and policies to support...

  • Regulatory Affairs Coordinator: Strategic Product Submissions

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

    **Job Title:** Regulatory Affairs Coordinator: Strategic Product SubmissionsAbout the Role:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Pfizer. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with local regulations and facilitating business continuity.Responsibilities:You...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Colombia Solventum A tiempo completo

    **Regulatory Affairs Specialist, Colombia (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...

  • Regulatory Affairs Coordinator Expert

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

    Pfizer seeks a skilled Regulatory Affairs Coordinator to join our team. This is a full-time opportunity based in Colombia - Bogota - Suba.The estimated salary for this position is $60,000 - $80,000 per annum, depending on experience and qualifications.About the RoleWe are looking for a highly motivated and detail-oriented individual to coordinate and execute...

  • Regulatory Affairs Specialist

    hace 2 meses

    Bogotá, Cundinamarca, Colombia Solventum A tiempo completo

    Job Description: Regulatory Affairs Specialist, Colombia (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health,...

  • Regulatory Affairs Professional with Dermatology Expertise

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Job Description:We are seeking a skilled Regulatory Affairs Coordinator to join our team at Galderma, the leading dermatology company. In this role, you will be responsible for implementing regulatory affairs programs, processes, and policies to support product regulatory activities.About Us:Galderma is a pure-play dermatology category leader, present in...

  • Regulatory Affairs Specialist for Global Compliance

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a key member of our regulatory affairs department, you will be responsible for implementing programs, processes, and policies to support regulatory activities related to product regulatory, CMC regulatory, and scientific writing.Key...

  • Senior Director of Medical Affairs

    hace 3 semanas

    Bogotá, Colombia Novo Nordisk A tiempo completo

    Senior Director of Medical Affairs & Regulatory Affairs **Category**:Clinical Development **Location**:Bogota, Cundinamarca, CO **The Position** - As Senior Director of Medical Affairs and Regulatory Affairs at Novo Nordisk, you will provide strategic leadership and ensure the alignment of medical and regulatory strategies with the organization’s goals....

  • Regulatory Affairs Project Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Bostonscientific A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Intern to join our team at Boston Scientific. This is an exciting opportunity to gain hands-on experience in regulatory affairs and contribute to the development of innovative medical solutions.About UsBoston Scientific is a global leader in medical science, committed to solving the...

  • Regulatory Affairs Lead

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Allergan A tiempo completo

    Job Overview: At Allergan, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for developing and executing regulatory strategies in alignment with global and affiliate regulatory colleagues.Responsibilities:Develop and execute regulatory strategiesRepresent area on global regulatory product teamsLead...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completo

    **Job Summary:**We are seeking an experienced Regulatory Affairs Specialist to join our Stryker Group team in LATAM. The successful candidate will be responsible for executing regulatory affairs activities, collecting and maintaining files on RAQA intelligence, and identifying the need for new regulatory procedures.**Key Responsibilities:**

  • Regulatory Affairs Coordinator

    hace 3 semanas

    Bogotá, Colombia Pfizer A tiempo completo

    Regulatory Affairs Coordinator Location: Colombia - Bogota - Suba Time Type: Full-time Posted: 3 days ago JOB RESPONSIBILITIES: Participate in the planning of Regulatory strategies for product submissions and lifecycle, including APIs related to products under her/his responsibility. Coordinate and execute activities related to: Dossier...

  • Dermatology Regulatory Affairs Professional

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Galderma, a pioneering dermatology company with a unique legacy and decades of innovation, is the emerging leader in its category, present in approximately 90 countries. Our innovative portfolio is based on premium brand science and services that cover the growing dermatology market through Injectable Esthetics, Dermatological Care, and Therapeutic...

  • Regulatory Affairs Specialist for Latin America

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma Pharma S.A A tiempo completo

    Galderma Pharma S.A. offers a competitive salary of $80,000 to $100,000 per year in Bogotá, Colombia.About the JobWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Latam. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs and processes to support our activities in...

  • Senior Regulatory Affairs Professional

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completo

    Stryker Corporation Job OpportunityWe are seeking a Senior Regulatory Affairs Specialist to join our team in Bogota D.C., Colombia.Estimated Salary: $60,000 - $80,000 per annum.About the RoleThis is a full-time position with hybrid work flexibility.The ideal candidate will have 4+ years of experience in regulatory affairs and a strong understanding of...

  • Regulatory Affairs Coordinator Latam

    hace 1 mes

    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...

  • Senior Director Of Medical Affairs

    hace 2 semanas

    Bogotá, Colombia INGEPSY A tiempo completo

    We are seeking an experienced and dynamic Senior Director of Medical Affairs and Regulatory Affairs with exceptional leadership skills to oversee and drive the strategic direction of the medical and regulatory functions within our organization. The ideal candidate will be responsible for leading the development and execution of medical and regulatory...

  • Regulatory Affairs Strategist for Latam Markets

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma Pharma S.A A tiempo completo

    Job Description:Core Mission: As a Regulatory Affairs Strategist, you will implement regulatory programs, processes, and policies to support regulatory activities related to product regulation, drug CMC regulatory, and scientific writing in accordance with health authorities.Responsibilities:Implement regulatory programs and policies for preparation,...