Senior Executive, Regulatory Affairs

DKSH Malaysia Sdn Bhd; Selangor; On-site; MYR 50,000 - 70,000; Full time

Job summary

A leading quality assurance firm in Malaysia is seeking a qualified individual to supervise the execution of quality assurance, safety, health, and environmental regulations. The successful candidate will manage operations efficiently, ensure compliance with laws, and provide training on quality standards. A diploma in Science, Chemistry, or Pharma is required, along with proficiency in quality assurance tools and local regulations.

Qualifications

• Understanding of local and international quality standards.
• Ability to coordinate quality development activities.
• Competence in managing day-to-day operating expenditures.

Responsibilities

• Supervise the execution of QA, SHE, and REG policies and standards.
• Support management in operating expenditures.
• Conduct investigations of non-conforming regulatory activities.

Skills

Quality assurance tools

Regulatory compliance

Data management

Training organization

Fluency in local language

Fluency in English

Education

Diploma/certification in Science, Chemistry, Pharma or related disciplines

Tools

Excel

Word

PowerPoint

Job description

Supervise the execution of 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

Responsibilities and Qualifications

• Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources
• Supervise the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards
• 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
• 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

Diploma/certification of Science, Chemistry, Pharma or related disciplines