Title:  Manager Regulatory Affairs

Job Summary

Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations

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/international quality standards
• Develop and maintain quality assurance systems, including the development of quality checklists, supporting tools and techniques
• Develop and follow up on corrective and preventive actions on regulatory affairs' activities - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to ensure consistent implementation and full compliance across the country
• Recommend improvement on policies, practices and processes related to quality assurance (QA), safety, health & environment (SHE) and registration (REG) to ensure the attainment of quality standards
• Develop and conduct quality management trainings - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to enhance employees' awareness of quality and create a culture of continuous improvement
• Manage the review with local management team on Regulatory Affairs' activities and updates to obtain commitment on local regulatory affairs implementation
• Provide technical advice and support to internal stakeholders on quality management matters
• Support the Head Regulatory Affairs and the Senior Managers  Quality Assurance (QA), Safety, Health & Environment (SHE) and Registration (REG) to ensure consistent implementation

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
• Demonstrate basic understanding of the Global Harmonized System (GHS)
• Demonstrate good working knowledge, comprehension and applications of local regulations
• Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
• Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
• Demonstrate fluency in English, both written and spoken

Education

Bachelor of Science, Chemistry, Pharma or related disciplines

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