Sr Manager/Assoc Director, Regulatory Operations

Erasca, a clinical-stage precision oncology company, seeks a senior regulatory operations manager to lead regulatory submissions, information management systems, and operational processes. This role reports to the Chief Regulatory Officer and supports portfolio development across hybrid or remote locations.

Responsibilities

• Partner with regulatory leads and stakeholders to define submission scope, timelines, and deliverables; track progress and manage risks
• Independently lead or coordinate standardized submissions such as DSURs and investigator's brochures
• Maintain regulatory submission records, correspondence, commitments, and trackers with accuracy and timeliness
• Establish and manage regulatory document templates, formatting standards, naming conventions, and archival practices
• Support or lead management of regulatory department budget, forecasts, and payment approvals

Requirements

• Bachelor's degree required; advanced degree preferred
• 6+ years of regulatory operations or related experience
• Knowledge of drug development strategies and regulations
• Experience supporting marketing applications (NDA/BLA/MAA) in operational capacity
• Proficiency with regulatory information management and electronic document management systems
• Strong project management and cross-functional collaboration skills
• RAC certification preferred