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 Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our product regulatory activities.

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 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.
  • Assist in preparing literature for new products and revising existing literature.
Requirements:
  • Master's / Bachelor's Degree or equivalent experience/qualification.
  • Minimum 4 years of experience in Regulatory Affairs, preferably 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.
  • Autonomy and ability to work independently.

Galderma is an equal opportunities employer and welcomes applications from diverse candidates. We offer a dynamic and inclusive work environment, opportunities for growth and development, and a competitive compensation package.



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