Job Description

About Us

MHP-Miracle Health Products Sdn Bhd is a leading and trusted name in the health and pharmaceutical industry, dedicated to enhancing lives through high-quality, innovative products. We are committed to excellence, integrity, and strict adherence to global regulatory standards. As we continue to expand our portfolio and market presence, we are seeking a dedicated and meticulous Regulatory Affairs Executive to join our dynamic team.

The Role

We are looking for an experienced Regulatory Affairs Executive to ensure our company's products comply with all applicable regulations and quality standards. You will be the cornerstone of our compliance strategy, managing certifications and acting as the key liaison with regulatory bodies. Your expertise will be critical in navigating the complex regulatory landscape and ensuring the seamless market entry of our products.

Key Responsibilities

Manage and maintain all company certifications, including but not limited to:

ISO

(e.g., ISO 13485, ISO 9001)

GMP

(Good Manufacturing Practice) for health supplements and cosmetics

GMP Pharmaceutical

HACCP

(Hazard Analysis Critical Control Point)

MeSTI

(Malaysia Good Service Practice) Prepare, compile, and submit regulatory documents and dossiers to the Ministry of Health (MOH), NPCB, and other relevant authorities (e.g., MDA, MITI) for product registration and renewal. Stay abreast of new and changes in existing regulations, guidelines, and standards, and communicate their potential impact to the management team. Liaise directly with government agencies and regulatory bodies to facilitate audits, inquiries, and submissions. Provide regulatory guidance and support to cross-functional teams including R&D, Quality Assurance, Production, and Marketing to ensure compliance from product development to launch. Review and approve product labeling, artwork, promotional materials, and technical documentation for regulatory compliance. Manage the renewal of licenses, permits, and product registrations in a timely manner. Coordinate and host external audits, ensuring all necessary documentation is prepared and follow-up actions are completed.

Qualifications & Experience

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related field. Minimum of

1 year

of hands-on experience in a regulatory affairs role within the pharmaceutical, nutraceutical, or cosmetic industry.

Proven experience in handling ISO, GMP, HACCP, MeSTI, and GMP Pharmaceutical certifications is mandatory.

In-depth knowledge of Malaysian regulatory requirements (MOH, NPCB) and application processes. Experience in preparing and submitting product registration dossiers.
Job Type: Full-time

Pay: RM2,000.00 - RM6,000.00 per month

Benefits:

Maternity leave Opportunities for promotion Parental leave Professional development
Work Location: In person