Regulatory Expert

2 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Executive to join our team at Pasona. As a key member of the regulatory affairs department, you will be responsible for ensuring compliance with government regulations and guidelines.

About Us:

  • Pasona is a leading provider of staffing solutions in Japan.
  • We have a strong presence in the market and a reputation for delivering high-quality services.

Key Responsibilities:

  • Liaise with government offices, authorities, and regulatory consultants on matters pertaining to regulatory activities, licenses, and permits for developing new and existing products.
  • Develop and recommend the best regulatory strategy for submissions, including regulatory timelines, while discussing with the head office in Japan during the planning phase for new products.
  • Review technical dossiers of new product applications and prepare additional documents where necessary to ensure smooth registration.
  • Conduct timely approvals of new products and renew existing product licenses, manufacturing site qualifications, post-approval variations, and other applications in accordance with government requirements.
  • Maintain appropriate GDP for drugs, medical devices, and cosmetics.
  • Evaluate the existing supply chain and advise on necessary changes to meet guidelines.
  • Manage and lead the implementation of various GDP training modules and programs.
  • Manage and respond to internal and external regulatory audits.
  • Handle post-marketing activities and pharmacovigilance, reporting requirements of company and product licenses to the government periodically or as required.
  • Review advertising, package labeling, and promotional items to ensure regulatory compliance and advise marketing staff in local or Japan as necessary.
  • Register and renew company licenses.
  • Prepare a monthly report on pharmacovigilance for the head office and report it to the President.
  • Provide guidance to project team members regarding regulatory compliance issues by maintaining an up-to-date understanding of government regulations and potential changes.
  • Build and maintain relationships with key regulatory officials to achieve positive and timely outcomes for product approvals.
  • Collect data relevant to any regulatory questions, issues, or problems and resolve them quickly.
  • Participate in monthly idea meetings when necessary and propose ideas for new products several times a year.
  • At the request of the head office, prepare regulatory procedures and necessary documents for applications to other countries.
  • Identify regulatory process improvements and work to improve and implement robust processes.

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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