Director of Regulatory Operations

Job Summary

A company is looking for a Director of Regulatory Operations.

Key Responsibilities

• Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management
• Oversee planning, tracking, publishing, and archiving efforts for regulatory submissions including INDs, NDAs, and CTAs
• Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs

Required Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred
• Minimum of 7+ years in Regulatory Operations within the pharmaceutical or biotech industry
• Proven experience implementing and managing Veeva Vault RIMs or similar regulatory systems
• Strong knowledge of global regulatory submission formats and requirements
• Experience building and scaling teams in a high-growth, agile environment