Tech Stack

Description

You will ensure regulatory data compliance across databases, execute activities such as label preparation and system updates, and support submissions and approvals of market licenses. This 12-month contract role offers the opportunity to work with a global CRO while supporting a single sponsor, balancing multiple activities in a high-trust environment.

Requirements

• Some experience in regulatory environment or equivalent combination of education and experience
• Experience preparing submissions for Colombian Health Authorities preferred
• Bachelor's Degree in Engineering, Pharmacy, or Life Science
• Intermediate English writing and reading skills
• Ability to manage complex data using Excel spreadsheets

Responsibilities

• Execute post-approval activities including database reviews and stakeholder communications
• Update systems with regulatory data and documents
• Review label compliance in internal systems
• Execute timely submissions of changes, amendments, rectifications, and renewals
• Support regional team with product submission schedules and pipeline management