Director, Global Regulatory Lead - Oncology

How you will contribute: Oversee and execute regulatory activities for one or more complex oncology projects; support assigned projects. Serve as Global Regulatory Lead (GRL) on Global Project Teams; may lead Global Regulatory Sub-teams (GRT). Act as Primary FDA contact; accountable for US FDA submissions and approvals and for timely, high-quality submission execution (e.g., NDA/BLA/MAA). Collaborate with global regions to develop and execute global regulatory strategy for the project(s). Communicate regulatory developments impacting success; participate/lead cross-functional taskforces. Develop/author and execute global regulatory strategies; monitor regulatory/access trends to strengthen development plans. May partner with market access colleagues on regulatory/agency/HTA value evidence interactions. May participate in due diligence regulatory assessments for licensing; identify resource gaps and present to senior management. Minimum Requirements/Qualifications: Bachelor’s degree required; scientific discipline strongly preferred; advanced degree strongly preferred. 8+ years of pharmaceutical industry experience, including regulatory and/or related experience. Strong drug development and regulatory knowledge; FDA knowledge required; EU/Canada/ROW a plus. Experience managing major regulatory filings and contributing to regulatory/development strategy. Ability to interpret complex scientific issues across projects; strong oral/written communication, timeline management, negotiation, integrity, adaptability. Strong, independent regulatory strategy skills; proactive issue identification and risk-mitigation solutions; effective global stakeholder collaboration. #J-18808-Ljbffr Scorpion Therapeutics