Regulatory Affairs Specialist

작업 내용

• Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions
• Responsible to ensure the application and renewal of appropriate licenses required for regulatory compliance are done appropriately.
• Product life cycle maintenance including: All Kinds of variations, license renewals, DMF, PMF applications.
• IND submission including new IND and amendments, CSR submissions.
• Local drug safety responsible person to timely report AE/SAE to global drug safety group.
• Be a key person to monitor local safety related issue.
• Support PV training to employees under SOP