Regulatory Affairs Specialist for Global Compliance

hace 4 semanas


Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo
About the Role

We 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 Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with health authorities' regulations;
  • Prepare, submit, and follow up on medical affairs and authorities (MAA) registrations and archive registration files;
  • Track product safety and maintain regulatory compliance with relevant legislation and regulations;
  • Manage regulatory reporting/documentation for internal and external audiences, including gathering data, preparing, reviewing, and approving compliance documents;
Requirements:
  • Minimum 3 years of experience in regulatory affairs;
  • Bachelor's Degree in Pharmaceutical Chemistry or a related field;
  • Intermediate-advanced English language proficiency;
  • Advanced knowledge and application of regulatory principles and procedures;
  • Ability to contribute to process design and improvement;
What We Offer:
  • An estimated salary range of $45,000 - $65,000 per year, depending on experience;
  • A dynamic and supportive work environment;
  • Ongoing training and professional development opportunities;


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