Senior Manager, Regulatory Affairs Project Management
New
A
Apogee TherapeuticsBiotechnology
RemoteFull-TimeManager
Salary150,000 - 170,000 USD per year
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Job Details
- Experience
- 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in life sciences, pharmacy, chemistry, or related field.
- 5+ years of professional experience, with at least 3+ years of project management in pharmaceutical or biotech.
- Demonstrated experience planning IND/CTA regulatory submissions.
- Experience planning BLA/NDA/MAA submissions.
- Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
- Hands-on Smartsheet experience.
- Proficiency in project management tools (e.g., ThinkCell, PowerPoint, Excel, SharePoint).
- Familiarity with regulatory systems (e.g., Veeva RIM).
- Knowledge of biotech processes, scientific terminology, and drug development concepts.
Responsibilities
- Track and coordinate timelines and deliverables for complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across regions.
- Work with the Regulatory team to translate strategic regulatory vision into actionable project plans.
- Facilitate cross-functional meetings to coordinate, plan, and track submission activities.
- Monitor CTA/IND submission status across assigned projects.
- Support strategic planning and risk mitigation efforts, including portfolio-level resource analysis.
- Evaluate, implement, and maintain project management tools, specifically Smartsheet.
- Design Smartsheet sheets, reports, dashboards, and forms and ensure integration with program plans.
- Troubleshoot and enhance PMO solutions and support system updates.
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