Regulatory Labeling Associate Director (Remote Eligible)
Core
Strategic global regulatory labeling management for therapeutic area products, ensuring compliance across FDA, EMA, and other health authorities.
Role type
Senior IC Regulatory Labeling Associate Director
Builds
Global product labeling (CCDS, USPI, EuSmPC) and packaging components for major and ROW markets
Domain
Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (regulatory documents)
Required skills
Global labeling governance, life-cycle management of CCDS, FDA/EMA regulatory strategy, health authority negotiation, AI-driven tool adoption, project leadership
Preferred skills
Life sciences degree background, experience with emerging automation technologies
Technologies
AI-driven tools, automation frameworks
Responsibilities
Lead label working groups and represent labeling at senior governance meetings; Develop and maintain global product labeling for multiple markets; Advise stakeholders on regulatory labeling requirements and oversee health authority interactions
Seniority
Senior, hands-on IC with strategic oversight
