Associate Director, Regulatory Submission Management
Core
Lead global regulatory submission planning and execution for complex biopharma programs, ensuring seamless delivery of marketing applications across multiple regions.
Role type
Senior IC regulatory submission management lead
Builds
Global regulatory filing plans and marketing applications (NDAs, MAAs, BLAs) for life science therapies
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory portfolio planning, multi-region submission execution, stakeholder facilitation, process improvement, project timeline management, health authority compliance
Preferred skills
Matrixed team leadership, biopharma submission lifecycle expertise, PMP certification, knowledge of US/EU regulatory requirements
Technologies
Regulatory submission systems, project management tools
Responsibilities
Develop global filing plans and program timelines, manage 2–4 major regulatory submissions simultaneously, lead RSM process improvement initiatives, coordinate cross-functional regulatory project teams, ensure compliance with ICH and local health authority requirements
Seniority
Senior, hands-on IC