Regulatory Affairs Manager(Immunology), Korea job opportunity at AbbVie.

Home Jobs In South Korea Tag: Korea Regulatory Affairs Manager(Immunology), Korea position at AbbVie


Date2026-03-17T14:16:27.622Z bot
AbbVie Regulatory Affairs Manager(Immunology), Korea
Experience: General
Pattern: Full-time
Country:
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Status:

Korea

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degreeGeneral
loacation Seoul, Seoul, South Korea
loacation Seoul, Seoul....South Korea
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Job DescriptionPRIMARY OBJECTIVE:To manage the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvalsTo provide regulatory input on regulatory matters to company personnel.This position will report to the RA Director with people management scope.CORE JOB RESPONSIBILITIES:Develop registration strategies and implement regulatory plan in accordance with strategic company objectives.Manage registration of new/line extension products, variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.Oversee regulatory affairs activities within the team, including regulatory submissions, approvals, and compliance.Manage safety update reports, certified product details and import permitsMaintain contact with governmental officials of Korea MFDS to facilitate evaluation processes.Liaise with operations department and others to maintain product changes and ensure these comply with regulations.Review and assess product labeling, packaging, and promotional materials for compliance with relevant regulations and codes.  Collaborating with cross-functional teams to identify and address regulatory compliance gaps and develop corrective actions.Analyzing and interpreting complex regulatory requirements and guidelines to determine their applicability to the organization's products and operations.Proactively identifying potential regulatory risks and proposing mitigation strategies to ensure compliance and minimize business impact.Provide support for marketing plans and launch teamsMaintain good knowledge of the relevant Regulations & Code.Bridge for translating regulatory strategies and goals into launch plans that drive the businessManage performance of the Therapeutic AreaCoach and develop team members to achieve their best targetShape the culture of the teamServe as a Back-up to the RA Director: Act as the deputy and take on the responsibilities of the RA Director in their absence. 

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