Job Description

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• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Assist to develop procedures to ensure regulatory compliance as and when required.
• Provide directions for developing, implementing, and maintaining the regulatory permit/license to comply with the Medicines & Poison Acts and meet Health Science Authority (HSA) requirements
• Handle regulatory documentation of pharmaceutical products
• Facilitate internal & external audits at site level
• Ensure third party warehouse follows strictly requirements for storage of Controlled Drugs Review and supervise
• Customer Service personnel on issues with poisons and controlled drugs in relation to shipments of goods
• Application for Import/Export licenses for Psychotropic Substances / Controlled Drugs to Central Narcotic Bureau (CNB) /HSA
• Ensure proper maintenance of controlled drugs records for CNB/HSA inspection
• Provide advice on any regulatory or quality issue and assist on other relevant issues in the capacity of a pharmacist
• Keep track of changes in country's regulatory requirements and provide regulatory intelligence to Management, Business Development and Sales team.
• Support in the maintenance of the Quality Management System to comply with requirements and international regulatory requirements.
• Maintenance of HSA importer license, wholesale license and other licenses for business operation.

• A registered pharmacist with a degree in Pharmacy and at least 2 years of regulatory affairs experience in a pharmaceutical company.
• Good knowledge and understanding of the HSA's rules and regulations.
• Must be meticulous with good organization and time management skills.
• Possess good communication and interpersonal skills.
• Able to work independently with tight deadlines
• Part time work arrangement can be considered