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DKSH

Regulatory Affairs Supervisor

Job Summary

Supervise the execution of product registration to ensure product quality, safety and efficacy in accordance with local registration (REG) policies

  • Minimum Qualification: Bachelor
  • Experience Level: Mid level
  • Experience Length: 2 years

Job Description

Job Requirements

  • Diploma/certification of Science, Chemistry, Pharma or related disciplines
  • Minimum one years’ experience in regulatory field and coordination with FDA.
  • 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 ideally in English, both written and spoken


Job Responsibilities

  • Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
  • Supervise and implement the regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
  • Prepare required product sample and documents for application of medical device licenses before importation.
  • Design quality management systems, include data management, quality criteria/checklists, supporting tools and techniques
  • Conduct investigations of non-conforming regulatory affairs activities, including identifying underlying causes, and suggesting corrective actions
  • Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG)
  • Identify training needs - quality assurance (QA), safety, health & environment (SHE) and registration (REG) - and organize training interventions to meet quality standards
  • Coordinate 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

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