Date Posted:
May 4, 2026
Position Title:
Senior Manager, Regulatory Affairs Project Management
Office/Company:
Apogee Therapeutics, Inc.
Party:
N/A
Office Code:
Job Number:
HC-05994
Reports To:
Location:
Remote
Contact:
Salary:
$150,000–$170,000
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities.Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts.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 the pharmaceutical or biotech industry preferred.
Responsibilities:
• Develop complex plans to enable successful regulatory submission activities and ensure cross-functional integration across regions
• Work with the Regulatory team to translate strategic regulatory vision into actionable project plans
• Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities
Qualifications:
• Experience with planning IND/CTA regulatory submissions required
• Familiarity with components of regulatory submissions required
• Experience planning BLA/NDA/MAA submissions required
Instructions:
Email to apply
Other:
Apogee Therapeutics is proud to be an Equal Opportunity employer.
