Senior Executive, Regulatory Affairs

DKSH Group; Petaling Jaya; On-site; MYR 100,000 - 150,000; Full time

Job summary

A multinational business services provider is looking for a Senior Executive in Regulatory Affairs based in Petaling Jaya. The role involves supervising quality assurance, safety, and regulatory compliance according to local and international laws. Key responsibilities include managing operational budgets, implementing policies, training staff, and liaising with stakeholders. A diploma in Science, Chemistry, or related fields is required, along with knowledge of quality assurance tools and regulations. This position is crucial for maintaining regulatory standards and improving quality processes.

Qualifications

• Demonstrate knowledge in quality assurance tools, concepts, and methodologies.
• Fluency in local language and ideally in English, both written and spoken.
• Good working knowledge of local regulations.

Responsibilities

• Support superior in managing day-to-day operating expenditures.
• Supervise the implementation of regulatory affairs' policies and standards.
• Design quality management systems including data management and quality criteria.
• Conduct investigations of non-conforming regulatory affairs activities.
• Liaise with internal and external stakeholders on regulatory queries.

Skills

Quality assurance tools

Dangerous Goods Regulations

Safety Data Sheets (SDS)

Global Harmonized System (GHS)

Office productivity tools (Excel, Word, PowerPoint)

English fluency

Education

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

Job description

Title: Senior Executive, Regulatory Affairs

Location: Petaling Jaya, MY

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 220594

Job Summary

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.

General Responsibilities

• 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

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 local language and ideally in English, both written and spoken

Education

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