Technology Officer (GMP Regulatory Affairs)

Have the ability to perform the following tasks: 1. Responsible for ensuring regulatory compliance for all manufactured products under GMP facility; 2. Keep abreast with the latest regulatory requirements and changes in requirements for all materials used in the facility, to provide regulatory input/requirements to company management and regulatory guidelines; 3. Develop and Implement SOP, Forms and others related to the Regulatory department; 4. Prepare regulatory submission to regulatory authorities in compliance with regulatory requirements including new drug applications, clinical trial applications, and variations; 5. Interact with regulatory agencies during the development, registration, and post-approval phases of the product lifecycle; 6. Ensure compliance with local regulatory requirements, NPRA and assist during Internal audits, External audits and Regulatory inspections; 7. Manage regulatory activities related to product labelling to ensure compliance with regulatory requirements; and 8. Develop and implement regulatory strategies to support the development, registration, and post-approval maintenance of pharmaceutical products. Qualifications and Experience: 1. Malaysian citizens; 2. The minimum qualification of a Degree in the field of Pharmacy is a registered Pharmacist in Malaysia under MOH and capable of obtaining and managing Poison A licensing of the premise 3. At least 2 years of experience in Regulatory Affairs in Pharmaceutical Industry; 4. In-depth knowledge of PICs guidelines, GMP requirements, ICH guidelines, Asean guidelines and OECD GLP testing guidelines; 5. Strong understanding of drug development including clinical trials and design and conduct are added advantages; 6. Experience in electronic documentation system related to product submission to NPRA; 7. Able to work independently and in a team as well; and 8. Possess great communication skills and critical thinking.