Associate Director Regulatory Affairs

A company is looking for an Associate Director, Regulatory Labeling. Key Responsibilities: Oversee the development and maintenance of global product labeling content and strategy Coordinate the creation of initial Company Core Data Sheet (CCDS), Prescribing Information (PI), and Patient Information Leaflet (PIL) in select markets Lead the Labeling Working Group (LWG) and ensure compliance with labeling regulations and guidance Required Qualifications: Bachelor's degree or advanced scientific degree (MSc, PhD, PharmD) preferred 5+ years of direct experience in regulatory affairs global labeling Experience in creating development labeling processes and documents (initial CCDS) Strong project management skills for regulatory labeling tasks In-depth knowledge of global labeling requirements, including USPI and SmPC

Feb 26, 2025 - 16:06

A company is looking for an Associate Director, Regulatory Labeling. Key Responsibilities: Oversee the development and maintenance of global product labeling content and strategy Coordinate the creation of initial Company Core Data Sheet (CCDS), Prescribing Information (PI), and Patient Information Leaflet (PIL) in select markets Lead the Labeling Working Group (LWG) and ensure compliance with labeling regulations and guidance Required Qualifications: Bachelor's degree or advanced scientific degree (MSc, PhD, PharmD) preferred 5+ years of direct experience in regulatory affairs global labeling Experience in creating development labeling processes and documents (initial CCDS) Strong project management skills for regulatory labeling tasks In-depth knowledge of global labeling requirements, including USPI and SmPC