Regulatory Affairs & QA Lead — Global Launch & Incentives

BREGO LIFE SCIENCES SDN. BHD.; Kuala Lumpur; On-site; MYR 60,000 - 120,000; Full time

Benefits offered by this job

Annual performance bonus

Overseas Incentive Trip

Education sponsorship (MBA)

Medical and Hospitalization benefits

Excellent career prospect

Personal and Professional Development

Job summary

BREGO Life Sciences is seeking a Regulatory Affairs & Quality Assurance Executive to manage regulatory submissions, product registrations, renewals and lifecycle activities across pharmaceutical and health supplements.

You will coordinate labeling, liaise with NPRA QUEST3+, overseas partners, and maintain GDP and QMS documentation. The role includes audits support, training, and continuous compliance improvements.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Science, Biotechnology, Biomedical Science or equivalent.
• Minimum 2 years of regulatory affairs and/or quality assurance experience in healthcare.
• Experience with NPRA QUEST3+ and MAL product registrations.

Responsibilities

• Manage regulatory submissions and product registrations.
• Support new product launches and international market expansion.
• Review labeling and coordinate with overseas distributors and consultants.
• Monitor regulatory changes and implement updates to products and documents.
• Maintain SOPs, forms, training records and regulatory trackers.
• Support audits and inspections, and drive CAPA and change control.
• Liaise with authorities, manufacturers, labs and internal teams.
• Provide regulatory training and maintain controlled documents.
• Identify compliance gaps and implement practical improvements.

Skills

Regulatory knowledge

Documentation skills

Submission management

GDP knowledge

Quality management

Attention to detail

Stakeholder management

Independent working

Compliance improvement

Education

Bachelor's degree in Pharmacy

Job description

BREGO Life Sciences is seeking a Regulatory Affairs & Quality Assurance Executive to manage regulatory submissions, product registrations, renewals and lifecycle activities across pharmaceutical and health supplements.

You will coordinate labeling, liaise with NPRA QUEST3+, overseas partners, and maintain GDP and QMS documentation. The role includes audits support, training, and continuous compliance improvements.