Senior Director/Executive Director, Global Regulatory Lead

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

Job summary

Scorpion Therapeutics seeks a Global Regulatory Lead to shape and execute global regulatory strategies across oncology programs. You will report to the VP, Regulatory Affairs and lead a team through dynamic, cross-functional collaboration.

You will drive regulatory submissions (INDs, BLAs, NDAs), interact with FDA and EMA, and stay ahead of industry changes to maximize global regulatory success in complex programs. This role is based in Bothell, WA.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• 10+ years of experience in global regulatory affairs in pharma/biotech (or equivalent).
• Proven success leading regulatory submissions and obtaining approvals in major markets.
• Oncology therapeutics experience strongly preferred.

Responsibilities

• Define and implement global regulatory strategies for oncology programs.
• Communicate developments to project teams and stakeholders; anticipate risks and devise solutions.
• Lead the Global Regulatory Team through coaching and mentoring.
• Collaborate with regional regulatory leads and vendors for compliant global submissions.
• Advocate for regulatory positions in governance and cross-functional committees.
• Identify regulatory risks and opportunities; develop mitigation strategies to enhance success rates.
• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs).
• Act as primary contact with global health authorities and lead FDA meetings.
• Monitor industry trends and regulatory changes and adapt strategies accordingly.

Skills

Regulatory leadership

Global submissions

FDA/EMA interactions

Oncology experience

Education

Bachelor’s degree in a scientific field

Job description

Position Overview

As the Global Regulatory Lead, you will develop and execute global regulatory strategies to maximize global regulatory success across complex and/or multiple oncology programs. You will report to the Vice President, Regulatory Affairs.

Responsibilities

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs.
• Communicate key developments to project teams and stakeholders; anticipate risks and devise solutions.
• Lead the Global Regulatory Team through coaching and mentoring.
• Collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions.
• Advocate for regulatory positions in governance and cross-functional committees with internal and external partners.
• Identify regulatory risks and opportunities; develop mitigation strategies to enhance success rates.
• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) while maintaining regional and global compliance.
• Act as the primary contact with global health authorities and lead FDA meetings.
• Monitor industry trends and regulatory changes and adapt strategies to mitigate impacts.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 10+ years of experience in global regulatory affairs in pharma/biotech (or equivalent).
• Proven success leading regulatory submissions and obtaining approvals in major markets.
• Oncology therapeutics experience strongly preferred.

Knowledge and Skills

• Direct experience leading regulatory submissions and health authority interactions (FDA, EMA, and others).
• Disciplined regulatory risk management and oncology therapeutic area expertise.
• Highly collaborative, open communication; strong analytical, organizational, and time management skills.
• Comfortable working with small teams under evolving scenarios and tight deadlines.
• Detail-minded yet flexible; manage multiple projects and reprioritize quickly.

Washington State Pay Range: $226,000 - $270,000 USD