Global Regulatory Submissions Director: Strategy & Execution

Regulatory Jobs; Redwood City (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines is seeking a senior Regulatory Operations leader to drive global submission execution and strategy. You will lead a submissions-focused team, partner with Regulatory Affairs, Medical Writing, Quality, and Clinical Operations, and oversee external publishing vendors to ensure high-quality, timely dossiers.

The role requires a 12+ year background in regulatory operations within biotech/pharma, strong leadership, and expertise in eCTD standards, RIM systems, and submission

Qualifications

• Bachelor’s degree in a life science; 12+ years in biotech/pharma/medical device.
• Seasoned people manager with proven leadership of high-performing teams.
• Global submission planning and eCTD/regulatory framework expertise.
• Proven ability to drive submission quality, process excellence, and timelines.
• Proficiency with DocuBridge and Veeva RIM for regulatory publishing.

Responsibilities

• Lead and be accountable for global regulatory submission execution across applications.
• Provide strategic and operational leadership within Regulatory Operations.
• Translate regulatory strategies into executable submission plans and timelines.
• Oversee planning, publishing, submission, and archiving of global dossiers.
• Lead, mentor, and develop a submissions-focused team.
• Oversee external publishing vendors to ensure quality and timeliness.
• Define and maintain submission SOPs, work instructions, and policies.
• Drive continuous improvement of submission processes for scale.
• Ensure alignment with Quality systems and regulatory requirements.
• Partner with cross-functional stakeholders for coordinated execution.
• Provide operational training to contributors involved in submissions.
• Communicate risks and issues with practical solutions.
• Advance cross-functional initiatives to improve regulatory effectiveness.
• Collaborate with Regulatory Systems to support submission execution.

Skills

Leadership

Global submissions

Regulatory operations

eCTD expertise

RIM proficiency

Project management

Cross-functional collaboration

Strategic thinking

Communication

Education

Bachelor’s degree in life science

Tools

DocuBridge

Veeva RIM

Smartsheet

Job description

Revolution Medicines is seeking a senior Regulatory Operations leader to drive global submission execution and strategy. You will lead a submissions-focused team, partner with Regulatory Affairs, Medical Writing, Quality, and Clinical Operations, and oversee external publishing vendors to ensure high-quality, timely dossiers.

The role requires a 12+ year background in regulatory operations within biotech/pharma, strong leadership, and expertise in eCTD standards, RIM systems, and submission