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REGULATORY AFFAIR EXECUTIVE

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AI-generated summary

  • Manage NPRA/DVS registrations: file variations, renew licenses, review labels, and ensure timely, accurate submissions.
  • Support health supplements, traditional medicine and veterinary portfolios.
  • Get NPRA/DVS exposure and shape market access!

RM 3000 - RM 4500

No.69 Jalan TPP 1/13, Taman Perindustrian, Puchong, Selangor

Job Description

 Job Responsibilities

  • Manage product registrations for Health Supplement and Traditional Medicine products with the National Pharmaceutical Regulatory Agency (NPRA).
  • Handle product variation submissions and regulatory updates with NPRA.
  • Coordinate Veterinary product registrations with the Department of Veterinary Services (DVS).
  • Prepare and manage applications and renewals for NPRA-related licenses and certificates.
  • Review labels, artworks, packaging materials, and product information to ensure compliance with regulatory requirements.
  • Ensure all registrations and submissions are completed accurately and within the required timeline.
  • Liaise with government authorities and internal departments on regulatory matters.
  • Maintain proper documentation and ensure all regulatory records are organized and up to date.
  • Support ad-hoc assignments and projects as assigned by management.

Job Requirements

 Job Requirements

  • Bachelor’s Degree in Science or equivalent qualification.
  • Minimum 2–3 years of experience in Regulatory Affairs, preferably in Health Supplements, Traditional Medicines, or related industries.
  • Meticulous and with an eye on details.
  • Self-motivated, responsible and able to work independently.
  • Good communication, coordination, and organizational skills.
  • Computer literate and familiar with Microsoft Office applications.
  • Proficient in English and Bahasa Malaysia. Proficiency in Mandarin will be an added advantage.
  • Possess own transportation.

Skills

Multitasking
Regulatory Compliance
Organizational Skills
Detail Oriented

Company Benefits

Panel clinics with medical benefits

Provides comprehensive healthcare coverage to ensure the well-being of employees

Performance Bonuses

Financial incentives based on individual and company performance to reward your hard work.

Competitive Compensation

Ensures employees are fairly compensated for their contributions.

Convenient location

Near to LRT station

Training & Personal Development

Offers employees opportunities for continuous learning and career advancement.

Employee Assistance Program

Provides confidential support for personal and professional challenges, including counseling services.


Additional Info

Company Activity

Last active - few hours ago

Career Level

Junior Executive

Job Specialisation


Company Profile

Esprit Care Sdn Bhd-logo-image

Esprit Care Sdn Bhd

Our company prides itself on its state-of-the-art highly automated, GMP-certified facilities, which allow us to produce a wide array of dosage forms, including capsules, tablets, softgels, probiotics, powder sachets, and liquid formulations. Leveraging our in-house R&D expertise, we collaborate closely with ingredient suppliers clients to develop tailored products that meet market demands and regulatory standards...