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 #J-18808-Ljbffr Immunome, Inc.