PRA ASSISTANT EXECUTIVE (MALAYSIA)

DXN Holdings Bhd; Jitra; On-site; MYR 40,000 - 60,000; Full time

Job summary

A prominent pharmaceutical company in Kedah is seeking an experienced individual for regulatory affairs. Responsibilities include preparing documentation for MITI applications, assisting in audits, and ensuring compliance with local and international regulations. Candidates should have a Bachelor's Degree in a relevant field and possess strong analytical and communication skills in both English and Bahasa Malaysia. This role offers opportunities for growth and requires collaboration with cross-functional teams.

Qualifications

• Minimum 1–3 years of experience in Product Regulatory Affairs or Quality Assurance.
• Fresh graduates with relevant exposure may be considered.
• Basic knowledge of local and overseas regulatory requirements.

Responsibilities

• Prepare documents for MITI applications and liaise with internal teams.
• Assist in audits requested by MITI officers.
• Prepare all required documentation and ensure validity for regulatory submissions.

Skills

Analytical skills

Organizational skills

Document control

Communication skills in English

Communication skills in Bahasa Malaysia

Education

Bachelor's Degree in Chemistry or related disciplines

Tools

Quality Management Systems (GMP, ISO, HACCP)

Job description

• Responsible to prepare documents including PID, Manufacturing Flowchart, Label, Finished

Good Photo, Lampiran 10, Lampiran 11, Lampiran 14, and any other documents required for the MITI application.

• Responsible to liaise with internal parties such as the production team, QA team, designer team, mushroom team, purchaser, planner, supplier (DXN Corporation (Ningxia) & Anxi), and other related departments to request samples, information, and supporting documents for MITI application and any related customs matters.

A) Audit for License Application

• Responsible to assist and attend the audit requested by the MITI officer to validate the application.

• Responsible to liaise with related departments to ensure the audit process runs smoothly and to ensure all relevant parties are informed, prepared, and ready for the audit in accordance with the products applied to MITI.

B) Finance – MITI Tax Exemption

• Responsible to prepare and provide Product Ingredient Declaration, Manufacturing Flowchart Diagram, Manufacturing Flowchart Photo & Finished Goods Photo.

C) Document Request and Document Validity for HS Code & MITI Application

• Responsible to prepare all required documentation and ensure the validity and accuracy of the information in the forms (Lampiran 10 & 14), Custom Form (CJ5) and related documents.

D) Other Responsibilities

• Responsible to carry out tasks assigned by HOD/Management and immediate superior.
• Responsible to follow up and ensure all assigned tasks are completed accordingly.
• Responsible to book BOD

Room and laptop for meetings.

Requirements

• Bachelor’s Degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Food Science, or related disciplines.
• Minimum 1–3 years of experience in Product Regulatory Affairs and/or Quality Assurance within pharmaceutical, traditional medicine, food, cosmetic, or household product industries.

Fresh graduates with relevant exposure may be considered.

• Basic knowledge of local and overseas regulatory requirements (e.g. NPRA, MOH, ASEAN or other regulatory authorities).
• Knowledge of Quality Management Systems such as GMP, ISO, HACCP, SOP documentation, and document control is an added advantage.
• Good analytical, organizational, and documentation skills with strong attention to detail.
• Good communication skills in English and Bahasa Malaysia, both written and verbal.
• Able to handle multiple tasks within timelines.
• Able to work independently, collaborate with cross-functional teams, and liaise with external parties and regulatory authorities.

Additional Information

• Country: MALAYSIA
• Department: (FARM)QUALITY
• Work Location: Lot 1109, Mukim Malau, Jalan Bukit Wang, Jitra
• Attachment: View Attachment
• External Link:

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