Regulatory Associate

Description

Summary: Seeking a detail-oriented Regulatory Associate to interpret data, perform quality control, and ensure regulatory compliance within a growing team. Highlights: 1. Opportunity to ensure regulatory compliance and data integrity 2. Support global/local teams with data management workload 3. Role for a quick learner with strong problem-solving skills ### **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** **Associate** **Regulatory Affairs** **Full Time**