Associate Director of Regulatory Operations

Job Summary

Leading regulatory operations for a development portfolio, the full-time Associate Director of Regulatory Operations will build and manage the Regulatory Information Management System, oversee submission planning and execution, and establish efficient processes for regulatory records and health authority correspondence in a remote setting.

Key Responsibilities

• Lead the selection, implementation, validation, and ongoing management of the Regulatory Information Management System
• Develop and maintain integrated plans, timelines, and trackers for regulatory submissions and key portfolio deliverables
• Oversee the operational preparation, quality control, publishing, and submission of various regulatory filings, ensuring compliance and accuracy

Required Qualifications

• Bachelor's degree in life sciences, information management, business, or a related field; advanced degree or relevant certification preferred
• At least 8 years of experience in Regulatory Affairs or Regulatory Operations within the biotechnology or pharmaceutical industry
• Demonstrated experience implementing or expanding a Regulatory Information Management System (RIMS)
• Strong knowledge of IND lifecycle management and global regulatory submission processes
• Experience managing multiple concurrent submissions and complex timelines in a clinical-stage environment