တိုင်ကြားမှု အောင်မြင်ပါသည်

Job Summary
Star Med is seeking a detail-oriented professional to coordinate regulatory and logistics-related activities in support of pharmaceutical operations. This role ensures timely documentation, compliance, and cross-functional coordination to keep products moving efficiently.
Job Description 
1.    Manage both pharmaceuticals and medical device products across Asia. 
2.    Communicate with regulatory bodies on regulatory affairs (e.g., product registration, change notifications) 
3.    Review, format all documents and responses prior to submitting to the FDA and also prepare and submit new online drug, medical device registration to FDA.
4.    Analyze label, ACTD dossier guidance, and regulatory compliance, regulation decisions before submission to FDA to identify trends and gaps or alignment in our current regulatory strategy in FDA and maintain regulatory files. 
5.    Provide regulatory advice to project teams and key internal / external stakeholders for start-up and maintenance activities in the projects. Ensures high quality of all regulatory documents.
6.    Manage team to ensure that all submissions and responses to competent authorities and Ethic Committees and are tracked in a timely manner 
7.    Act as primary point of contact for regulatory activities for the supply chain.

• Any graduated. 
• Experience in regulatory affairs, logistics coordination, or pharmaceutical operations.
• Strong knowledge of documentation control, compliance practices, and administrative follow-up.
• Good communication and coordination skills with the ability to work across teams and government office.
• Proficient in Microsoft Office, especially Excel, Word, and email correspondence.
• Detail-oriented, organized, and able to manage multiple tasks with accuracy and urgency.
• Familiarity with pharmaceutical industry procedures and local regulatory processes is an advantage.
• Able to work independently and maintain confidentiality in a fast-paced environment.