Regulatory Affairs & SCM -Pharmaceutical

◆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, quasi drugs, medical devices, PKRT, general goods, food and cosmetics.
◆Develop and recommend the best regulatory strategy for submissions, including regulatory timelines, while discussing with the manager and 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 products.
◆Conduct renewal of existing product licenses, manufacturing site qualification, post approval variations, and other applications in accordance with requirements of the government office.
◆Conduct researching, approval, changing, and renewal of Company licenses required for importing, storing, and selling in accordance with regulatory requirements.
◆Conduct researching, approval, changing and renewal of Halal certification.
◆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.
◆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
◆Other related tasks as assigned

◆Pharmacist Certification
◆English (Business level)
◆Who willing to help SCM par as needed）
◆Experience in FMCG company

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