Regulatory Affairs Executive – Pharma & MedTech

Hai-O Enterprise Berhad; Klang City, Port Klang; On-site; MYR 60,000 - 90,000; Full time

Job summary

Hai-O Enterprise Berhad in Klang, Selangor, seeks a Regulatory Affairs Executive/Senior Executive to ensure pharmaceutical and medical device products meet local and international regulatory requirements. In this role you will manage registrations, prepare submissions, monitor compliance with ISO and GMP standards, and liaise with health authorities.

The ideal candidate has a degree in Food Technology or equivalent and 2–5 years in regulatory affairs.

Qualifications

• Degree in Food Technology or equivalent.
• 2–5 years of experience in regulatory affairs in pharmaceutical industry.
• Familiar with ISO documentation control and GMP.
• Strong understanding of regulatory requirements and processes in Malaysia, as well as key international markets.
• Demonstrate solid track records in product registration.

Responsibilities

• Manage preparations and submissions related to product registration matters.
• Ensure compliance with local and overseas product regulatory requirements.
• Responsible for HALAL applications and related matters.
• Keep abreast of international legislation and customer practices for export markets.
• Collect and evaluate scientific data from R&D.
• Foster relationships with health authorities.
• Prepare and monitor license variations and renewals to deadlines.
• Advise on regulatory requirements and project-manage teams.
• Liaise and negotiate with regulatory authorities as needed.

Skills

Regulatory affairs

Education

Degree in Food Technology or equivalent

Job description

Hai-O Enterprise Berhad in Klang, Selangor, seeks a Regulatory Affairs Executive/Senior Executive to ensure pharmaceutical and medical device products meet local and international regulatory requirements. In this role you will manage registrations, prepare submissions, monitor compliance with ISO and GMP standards, and liaise with health authorities.

The ideal candidate has a degree in Food Technology or equivalent and 2–5 years in regulatory affairs.