Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Reg Affairs Specialist.

Key Responsibilities:

• Manage project-related documents and ensure compliance with SOPs
• Oversee financial reviews and assess budget impacts
• Coordinate regulatory submissions and manage project planning

Required Qualifications:

• At least one year of experience as a Study Start-up Trial Manager (STM)
• Experience in project documentation management and regulatory compliance
• Strong understanding of financial documents and budget management
• Proficient in project management and documentation systems (e.g., Clarity, EDMS, eTMF)
• Ability to manage multiple tasks and deadlines efficiently