Senior Executive, Regulatory Affairs

DKSH Malaysia Sdn Bhd; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading firm in quality assurance is seeking a professional to supervise the execution of quality assurance, safety, health, and environmental policies. The role includes ensuring regulatory compliance with local and international laws, managing operational expenditures, and designing quality management systems. Key qualifications include a diploma/certification in Science or related fields, along with strong knowledge in quality assurance tools, regulatory compliance, and fluency in local language and English.

Qualifications

• Knowledge of quality assurance tools, concepts, and methodologies.
• Good knowledge in Dangerous Goods Regulations and Safety Data Sheets.
• Understanding of the Global Harmonized System.

Responsibilities

• Supervise execution of QA, SHE, and REG policies and standards.
• Support managing day-to-day operational expenditures.
• Design quality management systems and supporting tools.
• Conduct investigations of non-conforming regulatory activities.
• Provide technical assistance on regulatory affairs issues.

Skills

Quality assurance knowledge

Regulatory compliance

Training organization

Fluency in local language and English

Proficiency in office tools (Excel, Word, PowerPoint)

Education

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

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

• 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