Regulatory Affairs & Quality Assurance Executive

BREGO LIFE SCIENCES SDN. BHD.

Kuala Lumpur

On-site

MYR 60,000 - 120,000

Full time

6 days ago

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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

Regulatory Affairs & Quality Assurance Executive

Our business is growing FAST and we are looking for the right people for our MAJOR business expansion plan.

Annual performance bonus

Overseas Incentive Trip

Employee education sponsorship (e.g MBA)

Medical and Hospitalization benefits

Excellent career prospect

Good Personal and Professional Development Program

Manage regulatory submissions and product lifecycle activities, including new product registrations, renewals, variations and maintenance of pharmaceutical, health supplement and other applicable products through NPRA QUEST3+ and relevant regulatory platforms.

Support new product launches and international market expansion by assessing country-specific regulatory requirements, preparing registration documentation, reviewing product labelling and coordinating with overseas distributors, consultants, authorised representatives and other relevant parties.

Manage other applicable regulatory submissions, including MAB/LIU advertisement applications, KKLIU approvals

Monitor changes in regulatory requirements and guidelines and coordinate with internal and external stakeholders to implement necessary changes to products, labelling, documentation or operational processes.

Maintain and continuously improve regulatory and quality documentation, including SOPs, work instructions, forms, product registration records, approved labels, licences, training records and regulatory trackers.

Support the maintenance of the company's Quality Management System and GDP requirements, including CAPA, deviations, change control, supplier/service-provider qualification, warehouse temperature monitoring and other quality-related activities.

Support internal, external, principal and regulatory audits and inspections, including audit preparation, documentation review, follow-up of findings and implementation of corrective and preventive actions.

Liaise with regulatory authorities, manufacturers, laboratories, principals, consultants and internal departments to address regulatory queries, obtain supporting documentation and ensure regulatory and quality activities are completed within required timelines.

Support internal regulatory and quality training and ensure relevant training records and controlled documents are properly maintained.

Identify regulatory or quality gaps and recommend practical improvements to strengthen compliance and day-to-day processes.

Knowledge and Experience:

Bachelor's Degree in Pharmacy, Pharmaceutical Science, Biotechnology, Biomedical Science or an equivalent science-related discipline.

Minimum 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within the healthcare industry.

Hands-on experience in new product registration and regulatory submissions is required.

Familiar with NPRA, QUEST3+ and MAL product registration requirements.

Experience in product renewals, variations, product labelling and regulatory documentation.

Experience or exposure to overseas market expansion and international regulatory requirements, including country-specific registration requirements, product documentation and labelling requirements.

Experience liaising with overseas distributors, regulatory consultants or authorized representatives would be an added advantage.

Exposure to GDP, SOP management, audits, CAPA, deviations and change control would be advantageous.

Key Skills:

Good understanding of Malaysian pharmaceutical and health-product regulatory requirements.

Strong regulatory documentation and submission skills.

Able to interpret and apply local and overseas regulatory requirements for new product registration and market expansion.

Good understanding of GDP and quality-management principles.

Able to manage multiple regulatory submissions, renewals and deadlines concurrently.

Strong attention to detail, organisation and follow-through.

Good communication and stakeholder-management skills.

Able to work independently and coordinate effectively with authorities, principals, manufacturers, consultants and internal departments.

Able to identify compliance issues and propose practical solutions.

The business language in BREGO is English, therefore fluency in this language is essential. Fluency in other languages(s) is advantageous.

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

BREGO Life Sciences is one of Malaysia’s fastest-growing healthcare companies, dedicated to revolutionizing patient care through cutting-edge innovations. Founded locally, we have expanded beyond borders and now export to 4 international markets. We specialize in breakthrough therapies and advanced medical technologies focusing on musculoskeletal health, nerve health, men’s health and gut health. Our solutions are designed to empower both healthcare professionals and patients, driving better outcomes and improved quality of life.

Make a difference with us - join a team dedicated to improving lives through pioneering healthcare innovations.

Perks and benefits