Regulatory Associate

Job Description

We are currently seeking a Regulatory Associate to join our growing team in Colombia.

Within the role, you will:

  • Review and interpret data to establish the system/tools required to be populated in line with client SOPs and/or business process documentation
  • Perform data entry and quality control tasks associated with regulatory systems
  • Review audit reports and resolve errors to ensure the integrity of data
  • Identify issues and provide input into solutions
  • Perform retrospective remediation tasks
  • Adhere to quality control procedures and standards related to the systems or tools to ensure Regulatory compliance
  • Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
  • Adhere to compliance standards
  • Act as Regulatory Data SME in regions supported
  • Produce country/regional reports as required
  • Support audit(s) as part of regulatory data/system scope

Desirable Skills and Experience

  • Minimum of 1 – 2 years of pharmaceutical experience is required
  • Experience of working in a highly regulated environment
  • Able to effectively communicate using the English language – intermediate to advanced in both written and spoken
  • Regulatory strategy experience
  • Ability to work with autonomy and as part of a team in a busy environment
  • Good accuracy and attention to detail
  • Problem-solving ability
  • Project management and coordination skills
  • Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards
  • A quick learner who is self-motivated and able to multi-task
  • Proficient in multiple software packages including MS Office.
  • Customer service and quality focused

Bogota, Colombia

Bachelor’s degree in Pharmacy/Pharmaceutical Chemistry, or life sciences related


Regulatory Affairs

Full Time