Regulatory Affairs Executive (Melaka)
Xepa-Soul Pattinson
Malaysia
30 hari yang lepas

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.
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