Job Description

Job Summary

Responsible for providing regulatory expertise to Business Unit Healthcare, DKSH Malaysia Sdn Bhd and for ensuring company\'s Pharmaceutical and Medical Device operations are in compliance with the requirements of the local Regulatory Authorities.

General Responsibilities

• Supporting the Regulatory Affairs team in submitting regulatory applications (submission, renewal and variation) and obtain timely approvals from the Regulatory Authorities
• Ensure proper documentation of all regulatory applications and communications with clients & Regulatory Authorities
• Keep abreast of updated regulations in Malaysia
• Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships
• Identify, develop and establish contact with new/potential/existing business partners in line with Company business development strategy and prioritizing business opportunities. Manage profit and loss by planning resources versus income
• Ensure company\'s operations are in compliance with all applicable government laws and regulations. Maintenance of the various licenses required to operate DKSH\'s warehouse and distribution services.
• Work with internal marketing teams to ensure content of all promotional material is fully supported by the Product Information and literature, and in accordance with the PhAMA Code of Conduct
• Provide support, training and advice to internal Business Unit Healthcare teams( HES, HCH, HED, HEA)

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
• Basic understanding of the Global Harmonized System (GHS)
• 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

• Minimum Bachelor Degree in Pharmacy.

Work Experience

• Minimum 4-5years work experience in Regulatory Affairs with Supervisory experience preferably in Pharmaceutical industry.

Requisition Number: 127852

Department: Client and Customer Services

DKSH