Senior Manager, Regulatory Affairs Project Management

Blend regulatory expertise with advanced PM to enable submissions across regions. Track timelines and deliverables for IND/CTA/BLA/NDA/MAA across regions. Translate regulatory strategy into actionable project plans with cross-functional coordination. Organize cross-functional meetings to plan and track submission activities globally. Monitor CTA/IND submission status across assigned projects. Support PMO tools, Smartsheet adoption, and reporting improvements. Bachelor’s degree in life sciences, pharmacy, chemistry, or related field. 5+ years of biopharma project management experience, with at least 3 years in PM. Experience planning IND/CTA regulatory submissions. Familiarity with components of regulatory submissions. Experience planning BLA/NDA/MAA submissions. PM tools Smartsheet ThinkCell PowerPoint Excel SharePoint; Veeva RIM preferred. Great culture aligned with our CORE values. Fast-paced biotech environment with cross functional collaboration. Competitive pay, bonus, equity, health and retirement benefits. Generous PTO, two company shutdown weeks, paid sick leave. Career growth opportunities and development resources. All team in person meetings to build relationships.