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Manager Regulatory Affairs

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This job is managing regulatory compliance with local and international laws for quality assurance and safety. You might like this job because it involves ensuring standards are met and developing quality management systems.

Undisclosed

Petaling Jaya, MY, MY, Kuala Lumpur

Job Description

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


Job Requirements


Company Benefits

Be entrepreneurial

Innovate, identify business opportunities, and take ownership to drive growth for our partners and yourself.

Learn and develop

On-the-job learning is complemented by more formal learning through our in-house Fantree Academy.

Work hybrid

In many roles, benefit from opportunities for flexible work arrangements from remote working to agile team set ups.


Additional Info

Company Activity

Last active - 1 hour ago


Company Profile

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DKSH

We provide reliable access to high-quality and responsible products and services, creating sustainable value for our partners and contributing to raising the quality of life in the communities we operate in by generating jobs, perspectives, and opportunities for people’s development and growth. Delivering life-saving drugs to hospitals, bringing high-quality products to remote villages, installing technology that...