Roles & Responsibilities:
• Provide compliance and operational oversight of the CCDS and Global Labeling processes.
• Support inspections and audits related to CCDS and labeling activities.
• Monitor and manage labeling change control metrics with focus on safety-related changes.
• Oversee labeling operations activities within internal systems (e.g., EAGLE, CCTA).
• Support global RA Labeling and CCDS activities to ensure timely, high-quality, and compliant submissions.
• Support global oversight of labeling submissions and approvals.
• Ensure country-level compliance with global labeling procedures.
• Maintain internal systems in line with company policies and procedures.
• Ensure quality compliance of marketed products and timely labeling submissions.
• Support review, development, and training on RA labeling tools, systems, practices, and policies.
• Support GxP audits and inspections related to CCDS and labeling.
• Conduct quality self-inspections and audits to ensure SOP compliance.
• Drive process efficiency, optimization, and global technical alignment for labeling.
• Coordinate training activities to ensure capability building and compliance.
• Contribute to global RA collaboration and establishment of best practices.
Qualification:
• Master’s degree in Pharmacy or other Life Science discipline (or equivalent experience).
Experience:
• Minimum 8 years of experience in Regulatory Affairs within a global environment.
• Experience managing projects and working in a matrixed organization.
• Strong knowledge of regulatory landscape, systems, and procedures for CCDS and labeling.
Skills:
• Proficiency in English language.
• Excellent communication, influencing, planning, and problem-solving skills.
• Ability to build and manage strong stakeholder relationships.
• Strong collaboration skills without direct reporting authority.
• Leadership mindset with focus on shared accountability and quality culture.
About the Organisation:
Astellas is a global pharmaceutical company focused on turning innovative science into value for patients, delivering high-quality medicines across therapeutic areas through strong regulatory, quality, and compliance frameworks worldwide.
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