Job Outline :
Responsible in implementing and adherence to regulatory submission plan for new product
registration and product license maintenance. Act as a liaison with regulatory authorities
pertaining to product registration matters in countries under her custodian.
Duties and Responsibilities :
To assist in interpreting regulatory requirements and impart information about the current approach of regulatory authorities to relevant departments in the company.
Make recommendations to management with regards to regulatory approach.
To review registered product dossiers for application filing to overseas. Ensure product dossier is in compliance with specific regulatory submission requirements in each country.
To collect, to collate and to evaluate all technical documents for adequacy and accuracy before compilation and submission of dossiers to regulatory authorities.
To adhere to product submission milestone and prepare dossiers and / or regulatory documents required by custodian countries in a timely manner.
Ensure timely registration of new products and regulatory compliance of marketed products.
To maintain product registration license by monitoring product renewal due date, and filing variation to drug authorities on any intended change in product registered particulars by the company.
To act as contact with the regulatory authority officials for queries pertaining to registering and maintaining products license.
Always respond and attend to queries posted by regulatory authorities in a timely manner.
Gain knowledge of applicable regulatory requirements in custodian countries, and provide input to management as to assure products are manufactured and marketed in compliance with appropriate regulations.
To participate in new product development, quality assurance, manufacturing and marketing team projects as to ensure all practices and outcomes are complied with regulatory requirements.
Minimum Requirements :
Bachelor’s degree in Science related field or Pharmacy with minimal 3 years proven experience in regulatory affairs within a pharmaceutical / healthcare company or regulatory agency.
Relevant experience in direct interaction with regulatory authorities.
Possess high levels of accuracy and attention to details. Good interpersonal skills.
Good in written and spoken English and Bahasa Malaysia is essential; Chinese as an additional language would be advantage.