ASEAN Regulatory Affairs Specialist: Drug & PDx Compliance

GE Healthcare; Kuala Lumpur; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical technology firm in Kuala Lumpur is looking for a Regulatory Affairs professional to manage local regulatory activities and ensure compliance with ASEAN pharmaceutical regulations. The successful candidate will work closely with regulatory authorities and central teams, provide regulatory advice, and manage the budgets. They should have at least a Bachelor's Degree and one year of related experience, along with strong analytical and communication skills. The company promotes a culture of compliance and continuous improvement.

Qualifications

• At least one year of experience with ASEAN pharmaceutical drug registration requirements.
• Experience in regulatory affairs and negotiating with regulatory authorities.
• Familiarity with Lean & Six Sigma methodologies.

Responsibilities

• Ensure regulatory compliance for Pharmaceutical Diagnostics in ASEAN.
• Drive relationships with regulatory authorities.
• Manage local regulatory activities and budgets.

Skills

Regulatory affairs in pharmaceutical products

Strong analytical skills

Excellent communication skills

Prioritization and planning

Knowledge of ASEAN regulations

Education

Bachelor’s Degree in a related field

Job description

A leading medical technology firm in Kuala Lumpur is looking for a Regulatory Affairs professional to manage local regulatory activities and ensure compliance with ASEAN pharmaceutical regulations. The successful candidate will work closely with regulatory authorities and central teams, provide regulatory advice, and manage the budgets. They should have at least a Bachelor's Degree and one year of related experience, along with strong analytical and communication skills. The company promotes a culture of compliance and continuous improvement.