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Regulatory Affairs Assistant

Job Summary

To affiliate and operate drug registration and other regulatory affairs. To communicate with client and authority for feasibility assessment and review requirements.

  • Minimum Qualification: Bachelor
  • Experience Level: Mid level
  • Experience Length: 1 year

Job Description/Requirements

Job Specifications

  • Support manager in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
  • Support the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
  • Prepare and assist in designing quality assurance systems, including the development of quality checklists, supporting tools and techniques
  • Identify, document and report on non-conforming regulatory affairs activities across the country
  • Analyze data to identify areas for improvement in the practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
  • Prepare training materials for quality management training - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - to enhance employees' awareness of quality
  • Assist in any 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

Job Requirements

  • Diploma/certification of Science, Chemistry, Pharma or related disciplines (B.Pharm is preferable)
  • Preferred to have related work experiences
  • 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 in English, both written and spoken
  • Able to travel at any time

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