Regulatory Affairs

Key Responsibilities:

• Regulatory Compliance – Ensure products comply with all relevant regulations; monitor changes and update internal processes.
• Product Registration & Licensing – Prepare, review & submit dossiers; manage renewals and verify authenticity of certificates/licenses.
• Documentation Management – Maintain accurate, complete, and updated regulatory records.
• Labeling & Advertising – Ensure packaging, claims & promotional materials meet regulatory standards.
• Liaison with Authorities – Handle submissions, inquiries, and follow-ups with regulatory bodies.
• Cross-Functional Support – Provide regulatory guidance to R&D, Quality, Marketing & Production teams.
• Post-Market Surveillance – Monitor complaints, recalls & ensure corrective actions.
• Regulatory Intelligence – Track industry trends and advise management on compliance strategy.
• Training & SOPs – Support regulatory training and maintain updated SOPs/guidelines.
• Customer & Operational Support – Coordinate with warehouse and customers for product delivery, documentation, and payment follow-ups.

Requirements:

• Strong knowledge of local & international regulations for:
• Pharmaceuticals, Supplements (MAL), OTC, Traditional Medicine, Medical Devices (MDA), Cosmetics/Skin Care (NOT), and Food products.
• Detail-oriented, organized, and able to manage multiple tasks and deadlines.
• Good communication & interpersonal skills (liaise with internal teams, suppliers & authorities).
• Proactive, independent, and a good team player.
• Skilled in documentation, dossier review, and regulatory submission.
• Familiar with post-market surveillance, complaints handling & corrective actions.

Job Types: Full-time, Permanent

Pay: RM1, RM2,500.00 per month

Benefits:

• Additional leave
• Free parking
• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development

Ability to commute/relocate:

• Ipoh: Reliably commute or planning to relocate before starting work (Required)

Education:

• Diploma/Advanced Diploma (Required)

Experience:

• product submission and registration: 3 years (Required)

Work Location: In person