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Manager Regulatory Affairs

1 month ago

Jakarta, Indonesia DKSH Full time

**Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:137312**Description**:
**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 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