Regulatory Affairs Executive

7 days ago


Shah Alam, Selangor, Malaysia Great Tree International Sdn Bhd Full time

**Job Overview:**

Great Tree International Sdn Bhd is seeking an experienced Regulatory Affairs Executive to join our team. As a Regulatory Affairs Executive, you will play a critical role in ensuring compliance with local regulatory requirements and maintaining effective relationships with local health authorities.

Key Responsibilities:

  • Support local regulatory work, including new product, device, and cosmetic product registrations, as well as variations and renewals.
  • Coordinate regulatory-related submissions and correspondence with local health authorities, such as the National Pharmaceutical Regulatory Agency (NPRA) and Kementerian Kesihatan Lembaga Iklan Ubat (KKLIU).
  • Handle Halal certificate applications and renewals.
  • Maintain regulatory-related databases and licenses, including product technical files, local product complaints, importation records, and regulatory licenses.
  • Assist with the maintenance and preparation of local quality management systems (SOPs) and ensure compliance with local regulatory requirements. Conduct quality checks of the company's products against finished product specifications.
  • Monitor product registration statuses, product renewals, license applications and renewals, and variation submissions.
  • Prepare, review, and submit dossiers to regulatory authorities for the registration of pharmaceutical products, traditional medicines, health supplements, and medical devices.
  • Attend to post-market surveillance activities and respond to requests from regulatory authorities.

**Benefits:**

  • An attractive salary package.
  • A comprehensive benefits program, including medical and dental insurance.
  • Opportunities for professional growth and development.


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