儲存工作 返回搜尋 職務說明 概要 類似職務Lead regulatory strategy for innovative pharmaceutical products.Manage a regulatory team and drive key product approval projects.關於我們的客戶Our client is a leading global pharmaceutical company dedicated to developing and commercialising innovative medicines that address significant unmet medical needs. With a strong global presence and diverse pipeline, the organisation continues to deliver impactful healthcare solutions worldwide.職務說明Lead regulatory submissions for new products and post-approval variations in TaiwanEnsure timely approval and maintenance of product registrations in line with business objectivesDevelop and execute regulatory strategies to support product launches and lifecycle managementManage interactions with health authorities and facilitate review and approval processesCoordinate and oversee responses to regulatory inquiries and deficiency lettersReview product labelling, prescribing information, and related documents to ensure regulatory complianceLead cross-functional discussions and provide regulatory guidance to business stakeholdersSupport regulatory planning for new product introductions and pipeline development projectsMonitor regulatory developments and assess potential business impactMaintain and improve regulatory procedures, policies, and SOPsLead regulatory projects and provide progress updates to local and global stakeholdersManage team performance and support capability development within the Regulatory Affairs function理想的應徵者Required QualificationsBachelor's degree or above in Pharmacy, Pharmacology, Biology, or a related disciplineApproximately 8 years or more of Regulatory Affairs experience within the pharmaceutical industry in TaiwanStrong knowledge of Taiwan pharmaceutical regulations and registration requirementsProven experience managing regulatory submissions and product lifecycle activitiesStrong communication, stakeholder management, and project coordination skillsAbility to communicate strategic and operational issues effectively to senior managementFluent English communication skills, both written and spokenPreferred QualificationsExperience with New Chemical Entity (NCE) submissionsKnowledge of clinical development and regulatory requirementsExperience within a multinational pharmaceutical environmentDemonstrated experience in regulatory strategy development and product launches福利待遇Opportunity to lead regulatory strategy for a diverse pharmaceutical portfolioExposure to product launches and pipeline development projectsClose collaboration with regional and global stakeholdersLeadership responsibility within a multinational pharmaceutical organisationAdditional compensation and benefits details: To be confirmed聯絡Benson Huang職務編號JN-102026-7125643手機號+88 6287298210職務概要職務類別生命科學子類別法規事務產業醫療保健/製藥地區台北市合約類型全職招募顧問名稱Benson Huang招募顧問電話+88 6287298210職務編號JN-102026-7125643辦公模式在家工作或混合工作模式
