REGULATORY AFFAIRS EXECUTIVE (DRUG / MEDICAL DEVICES)

E Health; Klang City; On-site; MYR 40,000 - 60,000; Full time

Job summary

A health supplement company in Klang City is seeking a Regulatory Affairs Executive to manage product registrations and ensure compliance. The role includes handling lifecycle management for drugs and medical devices, overseeing cosmetic notifications, and supporting halal certification processes. Candidates should have at least a year of experience in regulatory affairs, making this an exciting opportunity to develop your career in a vibrant work culture.

Qualifications

• At least one year of working experience in Regulatory Affairs.
• Familiarity with guidelines for Drugs, Medical Devices, and Health Supplements.

Responsibilities

• Handle product registration and lifecycle management.
• Oversee cosmetic notifications and ensure compliance.
• Manage Post Market Surveillance and reference standards.

Skills

Regulatory Compliance

Product Registration

Lifecycle Management

Post Market Surveillance

Job description

REGULATORY AFFAIRS EXECUTIVE (DRUG / MEDICAL DEVICES)

Looking for a platform to build your long term career in a health supplement company? This is a right platform for you with attractive career promotional plan. Most important, we emphasize "Live Learn Work Play" in a healthy culture working environment! Don't miss out this opportunity to join a great health supplement marketer company. We provide training for you to develop yourself.

Jobscope:

• Handling product registration, variation submissions, and lifecycle management for Drugs / Medical Devices / Health Supplement / Traditional and OTC.
• Also oversee cosmetic notification, renewal and notification changes.
• Handling classification submission for food and ensuring compliance with food guideline.
• Ensure products are renewed on time and apply for Import License and Indication Certificate for the renewed products.
• Handling the Post Market Surveillance (PMS) and reference standard request from NPRA, and addressing any warning received afterwards.
• Provide regulatory oversight on incoming samples, labeling, CoA, and marketed materials, including KKLIU advertisements.
• Act as a Halal Executive and submit renewal application to JAKIM/JAIS.
• Plan, design, and execute stability studies for registered products, including protocol preparation, laboratory engagement, and ensuring full compliance with DRGD requirements.
• Collaborate with other departments and advise to ensure all incoming, marketed labels and KKLIU ads comply.

Candidates must have at least one year of working experience in Regulatory Affairs.