Regulatory Affairs Assistant Executive: Product Compliance

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

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.