Regulatory Affairs Consultant – Global Labeling Lead
Job Description:
• Drive the labeling development and strategy, in-line with overall global strategy.
• Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
• Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
• Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds.
• Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy.
• Support global Health Authority interaction strategy regarding all aspects of labeling.
• Collaborate with global colleagues and partners as needed.
• Develop clear communications for senior management and labeling stakeholders.
Requirements:
• BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
• 6-8 years of relevant pharmaceutical Labeling/Regulatory experience.
• Thorough understanding of scientific principles and regulatory systems, relevant to drug development.
• Experience writing CCDS and local labeling documents for new products.
• Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required.
• Ability to prioritize and manage multiple high to medium complex projects simultaneously.
• Strong attention to detail.
• Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite.
Benefits:
• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development
Apply Now
Apply Now
• Drive the labeling development and strategy, in-line with overall global strategy.
• Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
• Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
• Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds.
• Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy.
• Support global Health Authority interaction strategy regarding all aspects of labeling.
• Collaborate with global colleagues and partners as needed.
• Develop clear communications for senior management and labeling stakeholders.
Requirements:
• BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
• 6-8 years of relevant pharmaceutical Labeling/Regulatory experience.
• Thorough understanding of scientific principles and regulatory systems, relevant to drug development.
• Experience writing CCDS and local labeling documents for new products.
• Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required.
• Ability to prioritize and manage multiple high to medium complex projects simultaneously.
• Strong attention to detail.
• Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite.
Benefits:
• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development
Apply Now
Apply Now