Regulatory Specialist
1 semana atrás
We are seeking a highly skilled Regulatory Specialist to join our team. As a key member of the team, you will play a critical role in ensuring compliance with regulations and facilitating the start-up process for clinical trials.
Key Responsibilities- Serve as a Single Point of Contact (SPOC) for assigned studies, working closely with project management and other departments.
- Review documents for completeness, consistency, and accuracy under senior staff guidance.
- Prepare site documents, including reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
- Bachelor's Degree in Life Sciences or a related field.
- 1-2 years of experience in clinical research regulatory, with particular experience in CEP/CONEP submissions, ICF review and adaptation, and ANVISA submissions.
- Advanced level of English skills.
- Great communication skills and ability to work in a team.
This is an exciting opportunity to work with a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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