Apogee Therapeutics is seeking a Senior Manager of Regulatory Affairs Project Management to optimize regulatory activities for clinical trials in a fast-paced biotech environment. The ideal candidate will have extensive project management experience, particularly in regulatory submissions, and a strong background in the pharmaceutical or biotech industry
Job Summary
This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions.
You will support optimization of Regulatory project plans, schedules, stakeholder communications, and Smartsheet operations, developing and managing high-visibility regulatory submission plans.
Apogee Therapeutics offers a great culture grounded in C.O.R.E. values, market-competitive compensation and benefits, and commitment to professional growth.
Matching Summary
Match Score: 85
Apogee Therapeutics is seeking a Senior Manager of Regulatory Affairs Project Management to optimize regulatory activities for clinical trials in a fast-paced biotech environment. The ideal candidate will have extensive project management experience, particularly in regulatory submissions, and a strong background in the pharmaceutical or biotech industry.
Salary
$150,000-$170,000
Skills & Requirements
Must-have
Global regulatory submission planning
IND/CTA/BLA/NDA/MAA submissions
Cross-functional integration
Smartsheet operations and reporting
Biotech drug development concepts
Nice-to-have
Proactive and structured problem-solving
Team player with valuable ideas
Thrives in dynamic environment
Key Requirements
Bachelor’s degree in life sciences or related field