Lead Regulatory Site Officer InsuLINK(m/w/x)

Requirements

• Significant industry experience in biopharmaceutical Regulatory Affairs
• Leadership experience with proven delivery and compliance
• In-depth knowledge of BLA process and Annex I
• Knowledge of CTD format and global regulatory requirements
• Strong technical regulatory writing skills
• Experience with health authority interactions
• Knowledge of GMP and quality systems
• Effective coaching and people development skills
• Degree in Science, Pharmacy, or equivalent qualification
• Proficiency in English
• Desirable knowledge of German and Chinese

Tasks

• Lead the InsuLINK regulatory site officer team
• Manage quality regulatory affairs within budget and schedule
• Report progress to the Global Program Quality Head
• Ensure insulin product compliance with international market regulations
• Author and manage CTD dossiers and technical documentation
• Define regulatory impacts for product and service changes
• Execute the regulatory compliance maintenance program
• Monitor and anticipate changes in the regulatory environment
• Implement regulatory procedures at the site level
• Maintain Site Master Files for both facilities
• Oversee regulatory aspects of product lifecycle management
• Lead health authority interactions and inspection preparations
• Coordinate responses to queries from global health agencies
• Oversee the quality regulatory affairs budget and costs
• Support quality systems implementation and GMP compliance
• Align regulatory strategies with Global Regulatory CMC

Work Experience

Education

Languages

Tools & Technologies