Empleos actuales relacionados con Regulatory Affairs Specialist - Bogotá, Bogotá D.E. - Galderma


  • 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 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 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 Galderma A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs, processes, and policies to support our product regulatory activities.Key ResponsibilitiesDevelop and implement regulatory affairs programs and...


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

    Join Zimmer Biomet's TeamZimmer Biomet is a leading medical technology company with a rich history of innovation and a commitment to improving the quality of life for people worldwide.What to ExpectA dynamic and collaborative work environmentOpportunities for professional growth and developmentA chance to work on cutting-edge medical technologiesImpact You...


  • 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 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

    Join Our Team at GaldermaWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Galderma, a leading dermatology company with a rich legacy and a commitment to innovation. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our activities related...


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

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our product regulatory activities.Key...


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

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in implementing regulatory programs, processes, and policies to support our product regulatory...


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

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the development of innovative...


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

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the development of innovative...


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

    At Galderma, we are seeking a highly skilled Regulatory Affairs Analyst to join our team. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific & medical...


  • 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 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 Galderma A tiempo completo

    {"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: *...


  • 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 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 Zimmer Biomet A tiempo completo

    About Zimmer BiometZimmer Biomet is a global medical technology leader with a nearly 100-year history of innovation. Our mission is to enhance patients' mobility and quality of life through our products and technologies.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will...


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

    About the PositionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our products with regulatory requirements.Key ResponsibilitiesSupport the implementation and execution of regulatory and quality plans, and...


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

    As a key member of the Werfenlife SA. team, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices. Your expertise in Quality Assurance and Regulatory Affairs will be instrumental in supporting the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a...

Regulatory Affairs Specialist

hace 2 meses


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

Company Overview: Galderma stands as a leader in dermatology, with a legacy of innovation and a presence in around 90 countries. Our commitment to delivering a science-driven portfolio of premium brands and services spans the dynamic dermatology market, encompassing Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our inception in 1981, we have dedicated ourselves to addressing the needs of the skin, collaborating with healthcare professionals to achieve superior outcomes for consumers and patients alike.

Core Mission: The primary objective of this role is to implement and manage Regulatory Affairs programs, processes, and policies that support regulatory activities related to product compliance, including Biologicals, chemical drugs, medical devices, and cosmetics. This encompasses Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing for both new and existing products, ensuring adherence to health authority regulations.

Key Responsibilities:

  • Develop and execute Regulatory Affairs programs and policies to facilitate regulatory activities concerning product compliance, including Biologicals, chemical drugs, medical devices, and cosmetics.
  • Oversee the preparation, submission, and follow-up of medical affairs and authorities (MAA), maintaining organized registration files.
  • Assist in drafting and refining manuscripts related to clinical studies and scientific reports, including summaries derived from raw data for regulatory submissions or internal use.
  • Monitor product safety and ensure compliance with relevant legislation and regulations.
  • Implement Regulatory Affairs plans for documentation and reporting, gathering data, preparing, reviewing, and approving compliance documents.
  • Support the creation of literature for new products and update existing materials, maintaining files on informative journal abstracts as per current or anticipated needs.

Qualifications:

Education: A Master's or Bachelor's Degree or equivalent experience is required.

Experience: A minimum of 4 years of recent experience in Regulatory Affairs, preferably within the pharmaceutical, cosmetic, or medical device industries.

  • Strong ethical standards.
  • Knowledge of drug, cosmetic, and medical device legislation.
  • Ability to work collaboratively within a team.
  • Strategic vision and independent work capability.

Employer's Rights: This job description is not exhaustive and may be subject to revisions. Employees may be assigned additional duties as necessary. Performance will be evaluated based on the execution of listed responsibilities. This description does not constitute a contract for employment, and either party may terminate employment at any time.