Regulatory Affairs Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo
Join Galderma's Team as a Regulatory Affairs Coordinator

Galderma, 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 dermatology products.

Key Responsibilities:
  • Implement Regulatory Affairs programs, processes, and policies to support regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing.
  • 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.
  • Track product safety and fulfill 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.
Requirements:
  • Master's / Bachelor's Degree or equivalent experience/qualification.
  • Minimum 4 years of experience in Regulatory Affairs, preferably in Peru, Ecuador, Bolivia, Venezuela, or Cono Sur.
  • Experience in the pharmaceutical, cosmetic, and/or medical device industry.
  • High ethical standards.
  • Knowledge of legislation related to medicines, cosmetics, and medical devices in Peru, Ecuador, Bolivia, Venezuela, and Cono Sur.
  • Teamwork and strategic vision.

Galderma is committed to empowering its employees and promoting their personal growth while ensuring business needs are met. We offer a dynamic and inclusive work environment that values diversity and respect for individual rights. If you are passionate about doing something meaningful for consumers, patients, and healthcare professionals, we encourage you to apply for this exciting opportunity.

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