Technology Officer (GMP Regulatory Affairs) - Contract

Full Time, onsite
National Institutes of Biotechnology Malaysia (NIBM)
Kajang/Bangi/Serdang, Malaysia

Salary undisclosed

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Have the ability to perform the following tasks:

Responsible for ensuring regulatory compliance for all manufactured products under th GMP facility;

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;

Develop and Implement SOP, Forms and others related to the Regulatory department;

Prepare regulatory submission to regulatory authorities in compliance with regulatory requirements including new drug applications, clinical trial applications, and variations;

Interact with regulatory agencies during the development, registration, and post-approval phases of the product lifecycle;

Ensure compliance with local regulatory requirements, NPRA and assist during Internal audits, External audits and Regulatory inspections;

Manage regulatory activities related to product labelling to ensure compliance with regulatory requirements; and

Develop and implement regulatory strategies to support the development, registration, and post-approval maintenance of pharmaceutical products.

Qualifications and Experience:

Malaysian citizens;

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;

At least 2 years of experience in Regulatory Affairs in Pharmaceutical Industry;

In-depth knowledge of PICs guidelines, GMP requirements, ICH guidelines, Asean guidelines and OECD GLP testing guidelines;

Strong understanding of drug development including clinical trials and design and conduct are added advantages;

Experience in electronic documentation system related to product submission to NPRA;

Able to work independently and in a team as well; and

Possess great communication skills and critical thinking.

For more info, please visit our website: https://nibm.my/v6/?page_id=135

Closing Date: 13 October 2024

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