Director, Filing Excellence Program Manager

The role

This person will provide project leadership for major global regulatory submissions including BLAs and MAAs. They will drive the end-to-end submission operating model and integrate work across multiple functional departments.

What you will do

• Drive integrated submission planning and execution by establishing the end-to-end submission plan and critical path.
• Translate regulatory strategy into an executable operating plan by partnering with functional leaders.
• Lead cross-functional submission readiness across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations.
• Drive critical submission milestones including readiness for Health Authority interactions and final submission readiness assessments.
• Establish submission governance and decision-making forums with escalation pathways and risk management.
• Provide visibility to submission readiness through dashboards, milestone tracking, and executive reporting.
• Lead rolling-submission planning and execution by defining module sequencing and dependencies.
• Lead Health Authority review-cycle execution including information requests and inspection readiness.
• Integrate USPI, PLI, BIMO inspection readiness, and launch readiness into the submission plan for FDA submissions.
• Drive resource and capacity planning for submission-critical workstreams.

Required qualifications

• BS in a scientific, technical, or related discipline
• 12 + years of experience
• 10+ years of biotechnology or pharmaceutical industry experience, including significant leadership of complex, cross-functional programs or projects
• Direct, hands-on experience leading the planning and execution of at least one major marketing application
• Strong understanding of eCTD structure, submission content dependencies, regulatory operations, and the end-to-end path from content development through review, approval, publishing, and submission
• Demonstrated ability to lead integrated submission planning, governance, readiness assessments, risk management, and executive-level reporting
• Proven ability to influence across functions and organizational levels, drive decisions without direct authority, and maintain execution discipline in complex, fast-paced environments
• Proficiency with Smartsheet or comparable project-management, collaboration, and portfolio-planning tools
• Strong facilitation, problem-solving, communication, and leadership skills
• Candidates must live locally and be able to work from Beam's Cambridge location 1 to 3 days per week as needed

Nice to have

• advanced degree
• preferably a BLA
• Experience managing Health Authority information requests, inspection-readiness activities, labeling, or other post-submission review activities
• Experience with cell or gene therapy programs and accelerated development or approval pathways

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.