Sr. RA Specialist Job | South Korea

Job Position: Sr. RA Specialist Job
Job Description: MSD – Korea – Requisition ID: REG003411 Obtain the regulatory approval timely through the best registration strategy, and maintain product license with local regulation and global compliance standard. l Achieve timely registration of new products and their variations/updates Ø Prepare and submit registration dossier in accordance with the plan Ø Communicate effectively with the Agency, HQ and appropriate experts l Support Regulatory Affairs Manager to develop assigned product specific plans and registration strategies Ø Analyze regulatory and product information Ø Define and anticipate potential issues l Maintain product licenses Ø Update safety and quality information timely Ø Meet the compliance for global RA database Ø Follow up post-approval activities (re-examination, DMF, annual report, etc.) Qualifications l Functional Knowledge: Drug Development, Pharmaceutical Regulations l Skills: Cross functional and interpersonal communication/relationship, Fluent…see more details

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