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Regulatory Affairs

hace 1 hora

Bogotá Cundinamarca, Colombia Test staffing A tiempo completo

Role: Global Regulatory Project Specialist | Regulatory Affairs

Location: Bogotá, Colombia

Duration: 6 months (short term contract)

Role Type: Contract

About the Role

The Global Regulatory Project Specialist will play a key role in supporting the digital transformation of the global artwork management process, ensuring alignment with regulatory requirements and operational excellence. This role will also contribute to regulatory performance initiatives and continuous business optimization across the organization.

You will collaborate closely with the Global Regulatory Artwork Excellence Lead and interact with regulatory, manufacturing, supply chain teams worldwide, supporting critical activities such as system validation, user testing, and training deployment.

Key Responsibilities

  • Support the Global Regulatory Artwork Excellence Lead in all activities related to the digital transformation of the artwork management process.
  • Assist country regulatory teams during User Acceptance Testing (UAT) as part of the GxP validation program for the new artwork solution.
  • Contribute to the planning and global deployment of training for the new artwork management system.
  • Support global regulatory performance improvement initiatives and business optimization projects.
  • Collaborate effectively with cross functional teams to ensure project milestones and deliverables are met.

Required Qualifications

  • Minimum 4+ years of experience in Regulatory Affairs, with specific experience in artwork management.
  • Bachelor's degree in sciences, Pharmacy, Industrial Engineering, Life Sciences, or a related discipline.
  • Strong ability to work independently and manage multiple tasks to meet project deadlines.
  • Results oriented mindset with strong analytical, critical thinking, and problem-solving skills.
  • Excellent interpersonal and communication skills, with the ability to collaborate in complex, cross-functional environments.
  • Fluent English proficiency (written and spoken) is required.

Job Type: Contract

Contract length: 6 months

Expected hours: 40 per week