Import/Export Coordinator (Licensed Pharmacist/IoR)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Import/Export Coordinator – Malaysia JOB DESCRIPTION At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. IMPORT/EXPORT COORDINATOR SUMMARIZED PURPOSE Responsible and accountable for the planning and execution of moderate to complex Import & Export activities for assigned studies in Malaysia. Reviews, collects, and/or prepares documents for import license and regulatory submissions. Responsible for coordination of Import & Export transactions through delivery to depots/Site while ensuring compliance with company requirements and applicable regulations. In addition to Import/Export Coordinator responsibilities, the role will also act as the Importer of Record (IoR) for assigned studies in Malaysia. The individual will support regulatory submissions, maintain regulatory documentation, interact with regulatory authorities, and ensure inspection and audit readiness in accordance with local regulatory requirements. ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION Import/Export Coordinator Responsibilities • Ensure that import & export activities are performed according to Thermo Fisher Scientific requirements, client requirements, and applicable regulations. • Ensure an Import & Export plan is in place for each assigned project. • Coordinate import & export transactions with customs brokers, freight forwarders, couriers, depots, and internal stakeholders. • Actively problem solve and suggest solutions to import/export challenges. • Maintain Import & Export files, metrics, and reports. • Meet with management to discuss import & export issues and provide recommendations. • Perform additional logistics and administrative activities according to business needs. • Participate in ongoing training related to import/export regulations and GDP/GMP activities. Importer of Record (IoR) Responsibilities • Act as the designated Importer of Record (IoR) for assigned studies in Malaysia. • Prepare, review, compile, and submit documentation required for import permit and regulatory applications. • Liaise directly with the National Pharmaceutical Regulatory Agency (NPRA) and other regulatory authorities as required. • Attend regulatory meetings and support submission activities, including physical submissions when required. • Maintain physical and electronic regulatory records in accordance with company procedures and regulatory requirements. • Ensure documentation remains inspection- and audit-ready at all times. • Travel to the office as required for document preparation, filing, record maintenance, and audit support activities. • Support regulatory inspections and audits related to IoR activities. JOB KNOWLEDGE Applies acquired job skills and company policies and procedures to complete assigned tasks. SUPERVISION RECEIVED Normally follows established procedures on routine work and requires instructions only on new assignments. BUSINESS RELATIONSHIPS Contacts are typically with individuals within own department and frequently with external stakeholders including customs brokers, regulatory authorities, couriers, depots, and study teams. QUALIFICATIONS Required: • Bachelor of Pharmacy (BPharm) or equivalent Pharmacy degree. • Registered Pharmacist with a valid Malaysian practicing license. • Based in Kuala Lumpur or surrounding area with the ability to travel locally as required. Preferred: • Knowledge of Malaysian pharmaceutical import/export regulations. • Experience in clinical supplies, logistics, regulatory affairs, import/export operations, or pharmaceutical environments. • Familiarity with clinical supply terminology, practices, and principles. • Proficiency in Microsoft Excel and Microsoft Office applications. KNOWLEDGE, SKILLS AND ABILITIES • Strong sense of ownership, accountability, and attention to detail. • Maintains awareness of local regulatory changes concerning Import & Export activities. • Daily interaction with customs brokers, forwarders, couriers, depots, and regulatory authorities. • Ability to maintain confidential, accurate, and audit-ready documentation. • Strong organizational and record management skills. • Strong communication skills both written and verbal. • Good level of English (verbal and written). • Ability to work independently while effectively managing multiple priorities. • Willingness to travel locally to NPRA and company offices as required.