Senior Director/Executive Director, Global Regulatory Lead
Immunome, Inc.
August 29, 2026
Remote friendly (Bothell, WA)
United States
Corporate Functions
Position Overview:
- Key decision-maker responsible for development and execution of global regulatory strategies for the therapeutic portfolio to maximize global regulatory success across complex/multiple projects. Reports 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 to ensure alignment.
- Anticipate risks and devise solutions, assessing likelihood of technical success.
- Lead the Global Regulatory Team; coach and mentor.
- 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.
- Identify regulatory risks/opportunities and develop mitigation strategies.
- Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) and maintain regional/global compliance.
- Act as primary contact with global health authorities and lead FDA meetings.
- Monitor industry trends and regulatory changes and adapt strategies.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 10+ years of global regulatory affairs experience in pharmaceutical/biotechnology (or equivalent).
- Proven success leading regulatory submissions and obtaining approvals in major markets.
- Oncology therapeutics development experience strongly preferred.
Knowledge/Skills:
- Direct experience leading regulatory submissions and health authority meetings; deep knowledge of FDA/EMA and other global health authorities.
- Disciplined approach to regulatory risk management and oncology compliance.
- Collaborative, self-starter; strong communication, analytical, organizational, and time-management skills.
- Ability to work under pressure with small teams and tight deadlines; detail-minded yet flexible.
- Manage multiple projects, timelines, and rapidly changing priorities.
Washington State Pay Range: $226,000 - $270,000 USD
- Key decision-maker responsible for development and execution of global regulatory strategies for the therapeutic portfolio to maximize global regulatory success across complex/multiple projects. Reports 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 to ensure alignment.
- Anticipate risks and devise solutions, assessing likelihood of technical success.
- Lead the Global Regulatory Team; coach and mentor.
- 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.
- Identify regulatory risks/opportunities and develop mitigation strategies.
- Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) and maintain regional/global compliance.
- Act as primary contact with global health authorities and lead FDA meetings.
- Monitor industry trends and regulatory changes and adapt strategies.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 10+ years of global regulatory affairs experience in pharmaceutical/biotechnology (or equivalent).
- Proven success leading regulatory submissions and obtaining approvals in major markets.
- Oncology therapeutics development experience strongly preferred.
Knowledge/Skills:
- Direct experience leading regulatory submissions and health authority meetings; deep knowledge of FDA/EMA and other global health authorities.
- Disciplined approach to regulatory risk management and oncology compliance.
- Collaborative, self-starter; strong communication, analytical, organizational, and time-management skills.
- Ability to work under pressure with small teams and tight deadlines; detail-minded yet flexible.
- Manage multiple projects, timelines, and rapidly changing priorities.
Washington State Pay Range: $226,000 - $270,000 USD