Kenvue 目前正在招聘 a:
我们做什么
在 Kenvue,我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础,植根于科学,是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。
我们是谁
我们的全球团队由 ~ 22,000 名才华横溢的员工组成,他们的职场文化中,每个声音都很重要,每一个贡献都受到赞赏。 我们热衷于洞察, 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心,成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本,热切关怀,以科学赢得信任,以勇气解决——有绝佳的机会等着您!加入我们,塑造我们和您的未来。有关更多信息,请单击 here.
Role reports to:
法规事务副总监位置:
Asia Pacific, China, Shanghai, Shanghai工作地点:
完全现场你会做什么
Position Summary
· Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both NPD and LCM projects. (e.g. ANDA/NDA, variations, renewals etc.)
· Build strategic regulatory insights in Big-health industry, provide innovative regulatory strategies/direction to the business for relevant selfcare products and seek potential regulatory innovation opportunities to accelerate & optimize the registration pathway.
· Provide thorough assessment to establish the feasible registration pathway of pipeline/projects /claim innovation with excellent execution to ensure fast introduction and enrich selfcare portfolio ((OTC, Medical Device, Health Food, etc.)
· End to end regulatory lead for submission strategy & dossier process also post submission communications ensure success registration & product speed to market.
· Establish and maintain good connections with regulatory authorities (Provincial FDA, NMPA, CDE, CFDI, etc.) to ensure effective product registrations. Support on Self care external engagement to positively shape the favorable regulatory environment.
· Proactively partner with internal business stakeholders (local, regional, global) to develop of innovative regulatory strategies & excellent execution to ensure that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
Required Qualifications
Required Minimum Education: Minimum Bachelor Degree in Pharmacy, Biology, Chemistry or related Life Sciences.
Required Years of Related Experience: Preferred minimum 3 years’ experience in Regulatory Affairs.
Required Knowledge, Skills and Abilities:Experience and knowledge of regulatory requirements relevant for the categories relevant for the company.
Skillful written and fluent spoken in English and Mandarin.
Competencies: Agile and efficient thinking; Able to think business strategically; excellent execution; Risk analysis/management;.
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