Director, Regulatory Operations, Systems

Scorpion Therapeutics; California (MO); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines in Redwood City, CA, is seeking a Director of Regulatory Operations to lead and scale global regulatory information management, focusing on Veeva Vault RIM platform and end-to-end submissions.

You will build a high-performing team, partner with Regulatory, Clinical, Quality and IT, drive digital transformation, and ensure readiness for structured data standards like IDMP and eCTD 4.0, supporting inspections and global filings.

Qualifications

• 12+ years in biopharma/medical device.
• 3–5 years with Veeva RIM.
• Global submission experience (EU, Japan, Canada).

Responsibilities

• Establish RIM strategy
• Oversee system administration
• Optimize processes for global regulatory submissions
• Drive digital transformation initiatives including automation and AI
• Collaborate across functions (Regulatory, Clinical, Quality, IT) to ensure compliance and readiness for structured data standards like IDMP and eCTD 4.0
• Build and mentor a high-performing team
• Support inspections and audits

Skills

Leadership

Global submissions

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s in life sciences

Tools

Veeva Vault RIM

Job description

Role

Director of Regulatory Operations, leading and scaling global regulatory information management (RIM) capabilities at Revolution Medicines, with a focus on Veeva Vault RIM platform.

Responsibilities

• Establish RIM strategy
• Oversee system administration
• Optimize processes for global regulatory submissions
• Drive digital transformation initiatives including automation and AI
• Collaborate across functions (Regulatory, Clinical, Quality, IT) to ensure compliance and readiness for structured data standards like IDMP and eCTD 4.0
• Build and mentor a high-performing team
• Support inspections and audits

Requirements

• Bachelor’s in life sciences
• 12+ years in biopharma/medical device
• 3–5 years with Veeva RIM
• Global submission experience (EU, Japan, Canada)
• Leadership experience
• Strong knowledge of GxP, electronic submissions, and regulatory standards

Preferred

• Advanced Veeva Vault RIM expertise
• Oncology development experience
• Digital transformation background
• Cross-regional submission familiarity

High Value

Oncology, RAS-addicted cancers, Veeva Vault RIM, structured data standards, global regulatory submissions (IND through post-market).

Work Setup

Based in Redwood City, CA; salary range $211K–$264K USD.