Regulatory Clinical Science Specialist (Temp-to-Perm)

Regulatory Clinical Science Specialist

Company Overview This organization is a commercial-stage biotechnology company focused on developing innovative immunotherapy and cell-based treatments designed to strengthen the body's natural immune response.

What You Will Be Doing

• Report to the Director, Regulatory Clinical Science and be responsible for contributing to the maintenance of global clinical regulatory compliance for investigational and marketed products and contribute towards the maintenance of study files in eCTD format.
• Support the organization in the management and conduct of clinical programs, focusing on accurately and efficiently filing appendices in clinical study reports and maintaining files to ensure ongoing compliance with regulatory requirements.
• Accurately and efficiently file documents for Appendix 16.1.4 and 16.1.5 of the clinical study report for all active clinical studies
• Ensure that all documents are properly labeled, dated, and stored in accordance with company policies and regulatory requirements
• Help with filing documents for closing clinical studies, ensuring that all necessary appendices are accounted for and properly stored in accordance with ICH E3 guidance
• Maintain accurate records of filed documents, including updating tracking systems and databases as needed
• Collaborate with team members to ensure that documents are filed and formatted correctly and that any issues are resolved promptly
• Create and maintain project plans
• Create, edit and adhere to Standard Operating Procedures (SOPs).
• Performs ad-hoc and cross-functional duties and / or projects assigned to support business needs and provide developmental opportunities.

What you will bring to the table :

Please reach out to Emily@ScientifficSearch.com to learn more about this fantastic opportunity! Reference Job# 19611