Assistant Regulatory Affairs
DKSH
Date: 1 week ago
City: Petaling Jaya
Contract type: Full time
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
Bachelor of Science, Chemistry, Pharma or related disciplines
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
- 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
Bachelor of Science, Chemistry, Pharma or related disciplines
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