Regulatory Science Lead — Oncology Submissions

OpenKrill; United States; Remote; USD 177,000 - 221,000; Full time

Job summary

Revolution Medicines, a global oncology company, seeks an Associate Director of Regulatory Science to lead regulatory strategies across clinical development. You will navigate US FDA and EU EMA guidance, provide cross-functional regulatory leadership, and drive submissions with rigor and clarity.

You will plan regulatory submissions, assess risks, mentor teams, and ensure continuous regulatory compliance while enabling timely development of innovative cancer therapies from Redwood City, CA

Qualifications

• Bachelor's degree and 9+ years in pharma/biotech with regulatory affairs exposure.
• Experience preparing and submitting regulatory documents for health agency reviews.
• Experience representing Regulatory Science on cross-functional teams and presenting to senior management.
• Excellent planning, organization, and ability to manage multiple projects with tight timelines.
• Strong knowledge of US FDA and EU EMA regulations; EU CTR submissions a plus.

Responsibilities

• Develop, implement, and maintain regulatory initiatives and procedures.
• Plan, prepare, and coordinate regulatory submissions with timelines.
• Use knowledge of regulations and guidance to support objectives.
• Identify risks and devise mitigation strategies proactively.
• Act as Regulatory Science SME on cross-functional teams.
• Perform regulatory research to inform business strategy and risk.
• Ensure no significant business interruptions due to regulatory issues.

Skills

Regulatory Affairs

Cross-functional teamwork

Communication

Education

Bachelor's degree in a relevant field

Advanced degree desirable

Job description

Revolution Medicines, a global oncology company, seeks an Associate Director of Regulatory Science to lead regulatory strategies across clinical development. You will navigate US FDA and EU EMA guidance, provide cross-functional regulatory leadership, and drive submissions with rigor and clarity.

You will plan regulatory submissions, assess risks, mentor teams, and ensure continuous regulatory compliance while enabling timely development of innovative cancer therapies from Redwood City, CA