• Regulatory Strategy & Implementation: Develop and execute regulatory plans to align with company objectives, ensuring timely approvals for new and line extension products.
• Regulatory Oversight: Manage regulatory submissions, approvals, and compliance, while overseeing the team's activities to maintain adherence to regulatory standards.
• Government Liaison: Maintain contact with Korea MFDS and other authorities to facilitate evaluations and ensure compliance with regulatory processes.
• Cross-Functional Collaboration: Work with operations, marketing, and other teams to ensure product changes meet regulatory requirements and identify compliance gaps.
• Regulatory Risk Management: Proactively identify and mitigate potential regulatory risks, ensuring compliance and minimizing business impact.
• Team Leadership & Development: Coach and develop team members to meet objectives while fostering a positive and performance-driven team culture.
자격 요건
• University degree in appropriate discipline
• More than 10 year experience in a regulatory position in the pharma industry with proven track records in driving new drug project, new launch
• Experience in Immunology will be preferred
• Experience in people management is a great plus (not must)
• Must be proficient in both spoken and written English.