Associate Director, Global Labeling

Summary

Join us on our journey to transform lives of patients with severe immune-mediated diseases as a Global Labeling Associate Director at Biogen's West Coast Hub.

Requirements

• 6+ years pharmaceutical/ biotechnology industry regulatory experience, including global, EU and US regulatory labeling
• Advanced knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development
• Experience in interpretation of global, EU and US regulations, guidelines, policy statements, etc
• Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts
• Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts
• Well organized, detail oriented, highly effective written and oral communication skills
• Bachelor's degree in a scientific or medically related discipline

Responsibilities

• Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI
• Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management
• Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies
• Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System

Benefits

• Medical insurance
• Dental insurance
• Life insurance
• Long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions