Regulatory Affairs Project Manager

Remote, USA • Full-time • Posted 2026-05-31

Apply Now

Job Titles: Program Manager III / Regulatory Affairs Program Manager III

Location: 100% Remote

Duration: 6 months

The Associate Director, Program Management plays an integral role in advancing gene therapy products through clinical development.
They will provide comprehensive program management and operational support for the Integrated Product Team (IPT), including creation and maintenance of integrated, end-to-end development plans and timelines.
This role partners with the IPT Lead to ensure the program team has clear direction and alignment to execute critical activities ranging from pre-clinical (IND-enabling) studies up through BLA submission (e.g., CMC, regulatory, clinical, medical).

In partnership with the IPT Lead, define scope, objectives, and deliverables for product candidates in stages of clinical development
Create and maintain integrated development plans that accurately capture timelines, decision points (i.e., stage gates), resource needs, and budget for multiple clinical programs
Track and coordinate critical activities required to advance programs into early-stage and/or registrational clinical studies
Provide general operational support to the IPT, including risk identification/mitigation, problem-solving, communication, and contingency planning
In partnership with IPT lead, ensure the team is prepared for stage-gates and governance interactions, including content development, stakeholder management, and pre-reads
Deliver timely updates to key functional stakeholders, leadership, and governance boards covering program status, risks/mitigation, scope changes, etc.
Document IPT meeting minutes, key decisions, risks/issues, and action items
Ensure the team communicates effectively and collaboratively, implementing team building techniques where needed to establish and maintain a high-performing teams
Facilitate creation of program budgets, resource models and long-range plans
Define resource needs (FTEs and financial) for each stage of development
Ensure all critical program documentation is organized, accessible, and archived
In partnership with the PM Center of Excellence, develop, implement, and champion PM best practices, processes, and strategies within the IPT and supporting functions
Assist with implementation of stage-gates and IPT operating model, including education to the organizations through functional team sessions and meetings with stakeholders/teams

Bachelor’s degree in a technical or life science discipline
5+ years of experience within the pharmaceutical/biotechnology industry
5+ years of project/program management experience
Excellent written and verbal communication skills with the ability to communicate effectively across disciplines and experience levels, including executive management
Experience in planning and/or managing cross-functional aspects of biopharmaceutical product development, including translational and clinical studies
Experience with SmartSheets and/or other project planning/management software
Ability to mentor, lead, and/or influence partners in a matrixed environment
Previous exposure to budgeting and resource management processes

Advanced degree (e.g., Master’s or Doctorate) in a technical or life science discipline
Project Management Professional (PMP) or an equivalent certification
Prior experience with developing advanced therapies (e.g., cell or gene therapy)
Experience working on/with global teams
Understands and interprets technical data related to biopharmaceutical product development

Apply tot his job

Apply To this Job

Apply Now