Senior Regulatory Affair Executive

Job Summary

Supervise the execution of 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

• Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
• Supervise the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
• Design quality management systems, include data management, quality criteria/checklists, supporting tools and techniques
• Conduct investigations of non-conforming regulatory affairs activities, including identifying underlying causes, and suggesting corrective actions
• Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
• Identify training needs - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - and organize training interventions to meet quality standards
• Coordinate quality development activities focusing on regulatory compliance such as audits, quality management reviews, and trainings
• Provide technical assistance to internal stakeholders on regulatory affairs related issues, and trouble shooting when necessary
• Liaise with internal and external stakeholders (i.e. government bodies) on regulatory affairs related queries, laws and regulations

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 local language and ideally in English, both written and spoken

Education

Diploma/certification of Science, Chemistry, Pharma or related disciplines