Senior Director/Executive Director, Global Regulatory Lead

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