Regulatory Affairs Senior Executive

United Italian Trading (M) Sdn Bhd; Petaling Jaya; On-site; MYR 60,000 - 110,000; Full time

Job summary

United Italian Trading (M) Sdn Bhd in Malaysia seeks a Regulatory Affairs Pharmacist to manage registrations for pharmaceutical and medical device products. You will coordinate applications, liaise with NPRA/MDA and vendors, ensure compliance, and lead audits.

1–2 years of relevant experience is preferred, with strong English and Bahasa Malaysia, and familiarity with Quest3+ and Medc@st. Must be a registered pharmacist with the Pharmacy Board Malaysia and hold a Bachelor's Degree in Pharmacy or

Qualifications

• Must be a Registered Pharmacist with the Pharmacy Board Malaysia.
• Bachelor's Degree in Pharmacy or equivalent recognised qualification.
• 1–2 years of regulatory affairs/regulatory healthcare experience preferred.
• Proficient with Quest3+ and Medc@st. regulatory systems.
• Strong English and Bahasa Malaysia communication skills.
• Good coordination, interpersonal and problem-solving abilities.
• Detail-oriented, independent, and able to meet deadlines.
• Proficient with regulatory documentation and record-keeping.

Responsibilities

• Prepare, coordinate, and submit regulatory applications and variations to authorities.
• Liaise with NPRA, MDA, and principals on regulatory matters.
• Ensure product information and submissions comply with requirements.
• Coordinate medical device registrations with Notified Bodies and authorities.
• Monitor regulatory status and renewals for all products.
• Lead regulatory and quality audits and implement corrective actions.
• Assist with Field Corrective Actions, recalls, and adverse event reporting.
• Stay updated on new regulations and maintain regulatory records.
• Assist in tender documentation with technical specs and supporting docs.

Skills

Regulatory affairs

English proficiency

Bahasa Malaysia

Communication

Coordination

Problem solving

Attention to detail

Independent work

Education

Bachelor's Degree in Pharmacy

Registered Pharmacist (Pharmacy Board Malaysia)

Tools

Quest3+

Medc@st.

Job description

Manage regulatory affairs and compliance activities for the Company's pharmaceutical and medical device products, including preparation and submission of applications, registrations, renewals, variations, and regulatory documentation to relevant authorities.

Key responsibilities

Prepare, coordinate, and submit applications, registrations, renewals, variations, and other regulatory documentation to the relevant authorities

Liaise with regulatory authorities, including the National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Authority (MDA), as well as principals/vendors on regulatory matters

Ensure product information, labelling, packaging, supporting documents, and regulatory submissions comply with applicable requirements

Liaise and work closely with Notified Bodies/Conformity Assessment Bodies on medical device registrations, change notifications, and other regulatory requirements

Monitor and maintain the regulatory and registration status of all Company products and ensure timely renewals where applicable

Lead and coordinate regulatory and quality audits, including preparation, documentation, liaison with auditors, follow-up on findings and implementation of corrective actions

Assist in coordinating and executing Field Corrective Actions (FCA), product recalls, and reporting of medical device malfunctions, incidents, and adverse events where applicable

Keep abreast of new and updated regulations, guidelines, and regulatory requirements affecting pharmaceutical and medical device products

Maintain proper regulatory records, licences, certificates, approvals, and related documentation

Assist in preparing and reviewing technical specifications and supporting documentation for tender submissions

About you

Must be a Registered Pharmacist with the Pharmacy Board Malaysia

Possess at least a Bachelor's Degree in Pharmacy or equivalent recognised qualification

Preferably 1–2 years of relevant working experience in regulatory affairs, pharmaceutical, medical device, or healthcare industries

Well-versed in regulatory systems such as Quest3+ and Medc@st.

Good command of written and spoken English and Bahasa Malaysia

Good communication, coordination, and interpersonal skills

Good problem-solving skills with the ability to work independently and manage deadlines

Computer literate and comfortable working with documentation and regulatory systems

Responsible, organised, detail-oriented, and self-motivated