Global Regulatory Strategy Lead, Oncology

Immunomeinc; Bothell (WA); On-site; USD 259,000 - 396,000; Full time

Job summary

Immunome, Inc. in Bothell, Washington, seeks a Global Regulatory Lead to shape and execute global regulatory strategies for our oncology portfolio, maximizing regulatory success across projects and life cycles.

You will partner with cross-functional teams and report to the VP of Regulatory Affairs. The role requires a decade of global regulatory affairs experience, a track record of successful submissions (INDs, BLAs, NDAs), and oncology therapeutics exposure, with strong leadership and

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• A minimum of 10 years of experience in global regulatory affairs in the pharmaceutical/biotechnology industry.
• 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 across therapeutic portfolio.
• Lead cross-functional teams and align stakeholders on regulatory plans.
• Manage and mentor the Global Regulatory Team and collaborators.
• Communicate regulatory positions and updates to governance bodies and partners.
• Identify regulatory risks and develop mitigation strategies.
• Oversee regulatory submissions (INDs, BLAs, NDAs) and interactions with health authorities.
• Monitor regulatory trends and adapt strategies to changing requirements.

Skills

Regulatory leadership

Regulatory submissions

Cross-functional collaboration

Excellent communication

Time management

Education

Bachelor's degree in relevant scientific discipline

Job description

Immunome, Inc. in Bothell, Washington, seeks a Global Regulatory Lead to shape and execute global regulatory strategies for our oncology portfolio, maximizing regulatory success across projects and life cycles.

You will partner with cross-functional teams and report to the VP of Regulatory Affairs. The role requires a decade of global regulatory affairs experience, a track record of successful submissions (INDs, BLAs, NDAs), and oncology therapeutics exposure, with strong leadership and