Labeling Strategy Associate Director
Core
Leads the development and implementation of regulatory labelling strategy for complex drug projects, managing Core Product Information and Market Product Information for assigned marketed or pipeline products.
Role type
Associate Director, Regulatory Labelling Strategy
Builds
Core Prescribing Information, EU Quality review of Documents, US Prescribing Information, Instructions For Use
Domain
Pharmaceutical regulatory affairs
Required skills
Regulatory strategy development, Labelling regulations interpretation, Risk assessment, Cross-functional leadership, Negotiation, Strategic communication
Preferred skills
Labelling development experience, Major markets labelling regulations knowledge, Advanced academic training (PharmD, PhD)
Technologies
None stated
Responsibilities
Lead development of labelling strategy aligned with overall regulatory strategy, Prepare and maintain high-quality Core Prescribing Information and US/EU Prescribing Information, Lead labelling negotiation strategies anticipating Health Authority perspectives, Evaluate and communicate global labelling regulations and business impacts, Justify labelling rationale to Senior Leaders, Assist in development of labelling policies and SOPs
Seniority
Associate Director, strategic leadership with hands-on execution