Manager Regulatory Affairs

Job Summary

• Manage APAC region implementation of registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations
• Develop and implement regulatory strategies and action plan of healthcare projects/products

General Responsibilities

• Manage departmental operating budgets and costs according to annual allocation to ensure efficient usage of resources, where applicable
• Manage the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local and international quality standards
• Develop and implement registration strategies and action plan of new registrations for responsible products
• Dossier review and regulatory evaluation for new projects/products
• Support responsible countries for product registrations and related regulatory activities
• Act as primary liaison with local regulatory affairs personnel on Regulatory Affairs issues
• Manage to review with local regulatory affairs personnel on Regulatory Affairs' activities and updates to obtain commitment on local regulatory affairs implementation.
• Work closely with regional marketing, supply chain and manufacturers to ensure smooth logistic flow
• Compilation of registration documentation in co-operation with supplier/manufacturers
• Maintenance of RA database of master dossiers, registration status and regulatory requirement
• Maintenance of registration life-cycle of existing products

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Demonstrate good knowledge of regulatory requirements and regulatory compliance of healthcare products
• Demonstrate basic understanding of the Global Harmonized System (GHS), especially ASEAN Harmonization of Healthcare product registrations
• Demonstrate good working knowledge, comprehension and applications of APAC regulations
• Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
• Manage and oversee team’s delivery of team/function goals to drive execution against goals set
• Drive and manage learning and development of team in the area of Regulatory Affairs and DKSH behaviors to achieve team/function goals
• Drive self-learning and improvement in the area of Regulatory Affairs and DKSH behaviors as part of continuous learning

Education

• Bachelor’s Degree or higher in Pharmaceutical Sciences or related field.
• 8-10 years experiences in regulatory affairs of pharmaceutical, medical devices, cosmetics & related healthcare products preferably with regional experiences.

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