Description
We are seeking a Clinical Trial Regulatory Specialist to join our team in Buenos Aires, Argentina. This is a hybrid role, requiring 2 days of office presence per week.
As a Clinical Trial Regulatory Specialist, you will perform assigned activities within the CTRA team, providing delivery and expertise in regulatory core submissions, site initiation, and study end submissions. You will work under supervision and guidance from senior regulatory colleagues to prepare technical components of regulatory core submissions, conduct quality control reviews, and attend client meetings.
Responsibilities:
- Prepare technical components of regulatory core submissions, such as EU Clinical Trial Regulation Part I and/or II
- Compile and perform regulatory core submissions under supervision
- Conduct quality control reviews of documents and track until final submission or delivery to client
- Attend client meetings and build client relationships
- Identify and report on areas of process and risk
- Ensure personal compliance with relevant quality standards and achieve utilization targets
- Maintain current knowledge of applicable regulations and guidelines
Qualifications:
- Minimum of a BA or BS degree
- Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
- Excellent presentation, documentation, influencing, and interpersonal skills
- Proficient computer skills in Microsoft Office Suite, web-based systems, and email
- Ability to travel approximately 10%
We offer a dynamic and supportive work environment, opportunities for career development and progression, and a comprehensive total rewards program.