Assistant Manager, Regulatory Affairs

1 week ago


Petaling Jaya, Selangor, Malaysia DKSH Group Full time

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Title: Assistant Manager, Regulatory Affairs

Location:

Petaling Jaya, MY, MY

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 173560

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 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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