Senior Manager, Regulatory Affairs Project Management
Related skills
excel powerpoint sharepoint smartsheet veeva rim📋 Description
- 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.
🎯 Requirements
- 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.
🎁 Benefits
- 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.
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