Global Regulatory Lead, Oncology — Senior Director

Immunome, Inc.; Bothell (WA); On-site; USD 226,000 - 270,000; Full time

Job summary

Immunome, Inc. is seeking a Global Regulatory Lead to shape and execute regulatory strategies across our oncology portfolio.

You will lead a cross-functional team, collaborate with regional leads and vendors, and partner with health authorities to align submissions with program objectives. The role reports to the Vice President, Regulatory Affairs and requires a proven track record in global regulatory submissions.

Qualifications

• Bachelor’s degree in relevant scientific discipline.
• 10+ years of global regulatory affairs experience in pharma/biotech.
• Proven success in leading regulatory submissions and obtaining approvals in major markets.
• Experience developing oncology therapeutics is strongly preferred.

Responsibilities

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs.
• Lead the Global Regulatory Team and collaborate with regional leads and vendors to ensure compliance and timely global submissions.
• Communicate key developments to project teams and stakeholders, ensuring alignment and sound judgment.
• Oversee regulatory submissions (e.g., INDs, BLAs, NDAs) and interactions with health authorities.
• Act as primary contact with global health authorities and lead FDA meetings.
• Monitor regulatory trends and implement continuous improvements.

Skills

Regulatory leadership

Regulatory submissions

FDA interactions

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in relevant scientific discipline

Job description

Immunome, Inc. is seeking a Global Regulatory Lead to shape and execute regulatory strategies across our oncology portfolio.

You will lead a cross-functional team, collaborate with regional leads and vendors, and partner with health authorities to align submissions with program objectives. The role reports to the Vice President, Regulatory Affairs and requires a proven track record in global regulatory submissions.