Director, Global Submission Management
$190.4k - $285.6kScorpion Therapeutics
General Summary: The Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs, including planning, submission, and closeout, to enable and advance global product registrations. Key Duties And Responsibilities: Oversee a defined portfolio of regulatory submissions from planning through closeout Develop and maintain submission plans, timelines, and tracking across multiple programs Ensure consistent use of submission management standards, tools, and processes Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define scope, milestones, and deliverables Coordinate cross-functional activities to ensure completeness, quality, and compliance Identify, manage, and resolve operational risks; escape when thresholds are reached Oversee status updates, issue logs, and portfolio-level reporting Support workload planning and capacity management Lead, coach, and support submission management staff and vendor FSPs Drive continuous improvement and knowledge sharing; adopt emerging technologies (incl. AI) Knowledge And Skills: Strong knowledge of global regulatory submission requirements, processes, and timelines Experience with submission/project management tools; manage multiple concurrent submissions Organizational, problem-solving, and cross-functional stakeholder management skills Education And Experience: Bachelor’s degree in Life Sciences/Regulatory Affairs/Project Management or related field 10+ years relevant experience with leadership across submission portfolios Experience across routine, regional, and lifecycle submissions; matrixed environments People-management experience; MS Project, Smartsheet, Veeva RIM Pay Range: $190,400 - $285,600; eligible for annual bonus and annual equity awards. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 4 days ago
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