Global Labelling Lead
Core
Shape and implement strategic regulatory labelling plans for the development and approval of innovative treatments within Plasma derived therapies.
Role type
Senior regulatory labeling lead (plasma derived therapies)
Builds
Regulatory labeling strategies and prescribing information for plasma-derived therapies
Domain
Healthcare / Clinical Research / Plasma-derived therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory labeling expertise, drug development process knowledge, pharmaceutical regulations knowledge, strategic planning, stakeholder management, project management, critical thinking, attention to detail
Responsibilities
Provide regulatory expertise and strategic guidance to Clinical, Pharmacovigilance, Legal, Scientific, and Commercial stakeholders; Manage preparation of strategic labeling input for regulatory strategies; Develop regulatory labeling strategies for new and revised prescribing information and packaging; Interpret scientific, medical, and regulatory data; Advise on current labeling requirements, templates, tools, and Health Authority guidance.
Seniority
Senior, hands-on IC
