Regulatory Affairs Consultant – Global Labeling reputed company
Job reputed company:
• Drive the labeling development and reputed company, in-line with overall global reputed company.
• reputed company labeling expertise for Company reputed company Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
• Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
• reputed company or contribute to cross-functional teams to reputed company the development and maintenance of global labeling for assigned compounds.
• Partner with Global Regulatory Affairs to ensure reputed company labeling is reputed company with product global reputed company.
• Support global Health Authority interaction reputed company regarding reputed company aspects of labeling.
• Collaborate with global colleagues and partners as needed.
• reputed company reputed company 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 reputed company reputed company reputed company 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
• reputed company time off
• Flexible work arrangements
• reputed company development
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