Remote Global Regulatory Leader – Oncology

Summit Therapeutics, Inc.; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies for oncology therapeutics from development through post-marketing. You will drive IND/CTA planning, guide BLA/MAA submissions, and partner with cross-functional teams to align regulatory content and strategy.

The role requires 15+ years in pharma/biotech regulatory activities, US leadership with exposure to EU/Japan/China, and strong leadership with program management.

Qualifications

• Bachelor's degree in life sciences; 15+ years in pharma/biotech regulatory activities.
• US leadership with exposure to EU/Japan/China regions.
• Extensive experience with marketing license applications (BLA, NDA, MAA) in late-stage development.

Responsibilities

• Independently lead global regulatory planning for IND/CTA approvals.
• Support subsequent BLA/MAA submissions.
• Represent regulatory in collaborations.
• Guide cross-functional teams on regulatory content and strategy.
• Develop tumor landscape assessments.
• Advise on laws and standards.
• Lead risk mitigation.
• Oversee labeling strategies.

Skills

Regulatory leadership

Global regulatory strategy

Project management

Cross-functional collaboration

Interfacing with authorities

Education

Bachelor's degree in life sciences

Job description

Scorpion Therapeutics is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategies for oncology therapeutics from development through post-marketing. You will drive IND/CTA planning, guide BLA/MAA submissions, and partner with cross-functional teams to align regulatory content and strategy.

The role requires 15+ years in pharma/biotech regulatory activities, US leadership with exposure to EU/Japan/China, and strong leadership with program management.