Dermatology Regulatory Specialist

hace 2 semanas


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

About the Role: We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Galderma.

Key Responsibilities:

We are looking for a detail-oriented and proactive individual to assist in the implementation of Regulatory Affairs programs, processes, and policies. This includes supporting regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing on both new and in-line products.

Duties and Responsibilities:

  1. Implement Regulatory Affairs programs, processes, and policies to support regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing on both new and in-line products.
  2. Prepare, submit, and follow-up on medical affairs and authorities (MAA) and archive registration files.
  3. 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.
  4. Track product safety and fulfill regulatory requirements compliant with legislation and regulations pertaining to the business.
  5. Implement Regulatory Affairs plans and processes for all activities related to Regulatory reporting/documentation for internal and external audiences.
  6. Assist in preparing literature for new products and revising existing literature.

Requirements:

We are looking for a candidate with a Master's / Bachelor's Degree or equivalent experience/qualification in a relevant field. The ideal candidate will have at least 4 years of experience in Regulatory Affairs, preferably in Peru, Ecuador, Bolivia, Venezuela, or Cono Sur. They should also have experience in the pharmaceutical, cosmetic, and/or medical device industry and possess high ethical standards.

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.



  • 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...


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

    Join Our Team at GaldermaWe are seeking a highly skilled Regulatory Affairs Analyst to join our team at Galderma, a leading dermatology company. As a Regulatory Affairs Analyst, you will play a critical role in ensuring the compliance of our products with regulatory requirements and ensuring the timely delivery of all information related to the management of...


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

    As a key member of the Galderma team, you will play a pivotal role in shaping the future of dermatology. We are seeking a highly skilled Regulatory Affairs professional to join our team and contribute to our mission to advance dermatology for every skin story.Key ResponsibilitiesImplement Regulatory Affairs programs, processes, and policies to support...


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

    Join Our Team as a Regulatory Affairs CoordinatorGalderma is a leading dermatology company with a rich legacy and a commitment to innovation. We are seeking a highly skilled Regulatory Affairs Coordinator to join our team.About the RoleThis is an exciting opportunity to work in a dynamic and fast-paced environment, supporting the development and...


  • Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    About Zimmer BiometZimmer Biomet is a global medical technology leader with a rich history of innovation and a commitment to improving the quality of life for people around the world. Our team members are part of a company that is shaping the future of healthcare and alleviating pain.What to ExpectAs a Regulatory Affairs Specialist, you will be responsible...


  • Bogotá, Bogotá D.E., Colombia Betsson Group A tiempo completo

    We are seeking a highly skilled Regulatory Compliance Specialist to join our Compliance department at Betsson Group. This exciting opportunity will involve working closely with a great team of lawyers and compliance personnel of different nationalities to ensure our regulatory obligations are met.The ideal candidate will have a university degree in law or...


  • Bogotá, Bogotá D.E., Colombia Werfen A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen.Key ResponsibilitiesEnsure compliance with regulatory and quality record management processes.Lead and manage non-conformities, follow-up plans for CAPAs.Document tracking and...


  • Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    About Zimmer BiometZimmer Biomet is a global medical technology leader with a rich history of innovation and a commitment to enhancing patient mobility.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory...


  • Bogotá, Bogotá D.E., Colombia Experian A tiempo completo

    At Experian, we're looking for a skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a crucial role in evaluating legal aspects during the development of new products and the execution of existing ones. Your expertise in data protection and privacy will help us navigate the complex regulatory landscape...


  • Bogotá, Bogotá D.E., Colombia Clínica Colombia ES A tiempo completo

    About the PositionClínica Colombia ES is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials and the regulatory approval of new drugs.Key Responsibilities:Regulatory Document...


  • Bogotá, Bogotá D.E., Colombia Betsson AB A tiempo completo

    Compliance Regulatory Affairs SpecialistAt Betsson, we strive to create a culture of compliance that sets the tone for our organization's commitment to ethical business practices. As our Compliance Regulatory Affairs Specialist, you will play a crucial role in ensuring our operations align with regulatory requirements in LatAm countries.Key responsibilities...


  • Bogotá, Bogotá D.E., Colombia Clínica Colombia Es A tiempo completo

    Regulatory Affairs Specialist Clinical TrialsAbout the CompanyIGC Pharma SAS is a subsidiary of a U.S. start-up clinical-stage pharmaceutical company based in New York, specializing in preventing and managing Alzheimer's and other CNS diseases. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and...


  • Bogotá, Bogotá D.E., Colombia Werfenlife SA. A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife SA.Main ResponsibilitiesSupport the implementation and execution of regulatory and quality plans.Perform regulatory activities for products marketed by Werfenlife SA.Key AccountabilitiesSupport RAQA management with a business focus.Ensure compliance with...


  • Bogotá, Bogotá D.E., Colombia International Flavors & Fragrances A tiempo completo

    Job Summary Regulatory Affairs Specialist. Focused on Product Compliance and business support. Accountable to execute regulatory strategy in the Andean Region. Main focal point to the Functional Ingredients Business. Good relationship skills and food regulatory knowledge (Andean) are required. Participation in Trade Associations is expected. English is a...


  • Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo

    **Job Summary:**We are seeking a highly skilled Regulatory Compliance Specialist to join our team at CooperVision. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local and global regulations related to medical devices.**About the Role:**In this exciting role, you will have the opportunity to work on...


  • Bogotá, Bogotá D.E., Colombia 535 ICR Colombia - COL A tiempo completo

    Project Manager - Language ServicesWe are seeking a highly skilled Regulatory Affairs Specialist to join our Language Services team at ICON, a world-leading healthcare intelligence and clinical research organization.Salary: $80,000 - $120,000 per year, depending on experience.Job Description:As a Regulatory Affairs Specialist, you will play a crucial role in...


  • Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Job SummaryWe are seeking a Regulatory Affairs Specialist to join our team at Boston Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.About the CompanyBoston Scientific is a global leader in medical science, committed to solving the challenges that matter most. Our mission to advance...


  • 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...


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

    Regulatory Affairs Coordinator - Job SummaryGalderma Pharma S.A seeks a skilled Regulatory Affairs Coordinator to implement regulatory programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific medical writing.Key Responsibilities:Implement Regulatory Affairs...


  • Bogotá, Bogotá D.E., Colombia Abbvie A tiempo completo

    Regulatory Affairs Specialist Job DescriptionKey Responsibilities:Develop and execute regulatory strategies to ensure compliance with global and affiliate regulations.Represent the area on global regulatory product teams and lead area regulatory product teams to identify and compile information for regulatory submissions.Interface with partner functions to...