Overview

• Salary

  6,000 MYR ~ 8,000 MYR

• Industry

  Manufacturing(Pharmaceutical/Medical Equipment), Trading Firm

• Job Description

  Job Purpose
  To sustain the sales and operations of the company, the Regulatory Affairs Specialist is:
  - Fully responsible for timely filing drug applications for new and existing products for Malaysia and Singapore
  - Responsible also for supporting the development, and evaluation of consumer products aimed at the market.
  - Responsible for supporting marketing activities for Malaysia and Singapore with his/her pharmacy knowledge such as safety and product information.
  - Responsible for supporting regulatory activities for Brunei.
  
  Detailed Duties, Responsibilities
  - Liaise with the government office, authorities and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits to developing new and existing products. Products include drugs, medical devices, general goods, food and cosmetics.
  - 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 to achieve timely and cost effective clearance/approval.
  - Review technical dossier of new products application and prepare additional documents where necessary to ensure a smooth register.
  - Conduct timely approval of new product
  - Conduct renewal of existing product licenses, manufacturing site qualification, post-approval variations, and other applications in accordance with requirements of the government office.
  - Maintain the appropriate GDP for drugs, medical devices and cosmetics.
  - Evaluate the existing supply chain and advise on necessary changes to meet the guidelines
  - Manage and lead the implementation of various GDP training modules and programs
  - Manage and respond to internal and external regulatory audit.
  - Handle post-marketing activities and pharmacovigilance. Then report requirements of company and product licenses to the government periodically or when it is required.
  - Review advertising, package labeling and promotional items to ensure regulatory compliance and give advice to marketing staff at local or Japan, if it is necessary to amend copy or any explanations. Then obtain permits from government office and authorities, if necessary.
  - Register and renew the 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 office, regulations and organizational structure and potential changes.
  - Build and maintain relationships with key regulatory officials influencing regulations, to achieve positive and timely outcomes for product approvals.
  - At the request of the head office, prepare the regulatory procedures and necessary documents for applying to other countries.
  - Identify regulatory process improvements and work to improve and implement robust processes.
  - In case any quality complaints are reported from the market、report the details to the head office in Japan following the designated report flow and format.
  - Others, if any instructed.