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