Compliance Officer

2 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time
Regulatory Affairs Executive Job Description

The successful candidate will be responsible for ensuring compliance with government regulations and guidelines, liaising with government offices, authorities, and regulatory consultants, developing and recommending regulatory strategies for submissions, reviewing technical dossiers of new product applications, conducting timely approvals of new products, renewing existing product licenses, maintaining appropriate GDP for drugs, medical devices, and cosmetics, evaluating the existing supply chain and advising on necessary changes to meet guidelines, managing and leading the implementation of various GDP training modules and programs, managing and responding to internal and external regulatory audits, handling post-marketing activities and pharmacovigilance, reporting requirements of company and product licenses to the government periodically or as required, reviewing advertising, package labeling, and promotional items to ensure regulatory compliance and advising marketing staff in local or Japan as necessary, registering and renewing company licenses, preparing a monthly report on pharmacovigilance for the head office and reporting it to the President, providing guidance to project team members regarding regulatory compliance issues by maintaining an up-to-date understanding of government regulations and potential changes, building and maintaining relationships with key regulatory officials to achieve positive and timely outcomes for product approvals, collecting data relevant to any regulatory questions, issues, or problems and resolving them quickly, participating in monthly idea meetings when necessary and proposing ideas for new products several times a year, and preparing regulatory procedures and necessary documents for applications to other countries at the request of the head office.

Requirements:

  • At least 3 years of working experience in Regulatory Affairs related roles.
  • Bachelor's degree in Pharmacy or related discipline.
  • Language requirements: Bahasa Melayu - Written & Spoken - Native (Required), English - Written & Spoken - Business level (Required).
  • Pharmacist Certification – Preferred.
  • Willingness to visit government offices to appeal and submit applications.
  • Ability to undertake business trips as necessary, up to 2 times a month.

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