Senior Manager, Regulatory Affairs Project Management

Apogee Therapeutics is seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities.

Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field
• 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry
• Experience with planning IND/CTA regulatory submissions
• Familiarity with components of regulatory submissions
• Experience planning BLA/NDA/MAA submissions
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications
• Experience supporting global interventional clinical studies and CTA submissions
• Hands-on Smartsheet experience
• Proficiency in project management tools (Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, Office Timeline Pro)
• Familiarity with regulatory systems (Veeva RIM)
• Knowledge of biotech processes, scientific terminology, drug development concepts
• Proactive and structured approach to problem-solving
• Strong organizational, communication, and problem-solving skills
• Ability to work independently and thrive in a dynamic environment
• Team player that contributes valuable ideas and feedback

Benefits

• Market competitive compensation and benefits package
• Base salary
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Competitive time off
• Dedicated paid sick leave
• Access to resources to further professional development