เกี่ยวกับตำแหน่งนี้
The Regulatory Affairs Lead in Thailand will be responsible for providing strategic regulatory advice, ensuring patient safety, and driving quality assurance within the organization.
หน้าที่รับผิดชอบ
• Provides strategic regulatory advice support for product development in regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programs, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
• Participates in skill development, coaching, and performance feedback of other regulatory staff working on the product/project
คุณสมบัติ
• Bachelor’s Degree in Life Science or related discipline, advanced degree a plus
• Significant experience in regulatory drug development, manufacture, commercialization or equivalent
• Proven successful leadership and project management experience
• Broad background of experience working in several groups in regulatory affairs or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
สิทธิประโยชน์
120,000 - 300,000 THB per month
