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：
Senior CMC Manager位置：
Europe/Middle East/Africa, United Kingdom, Reading, Berkshire工作地点：
混合你会做什么
The CMC Specialist is responsible for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and deploying regulatory technical content across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
• Acts as the CMC representative within cross-functional project teams. Accountable for assigned projects and activities, completing work within assigned product portfolio. Develops resolution proposals for regulatory CMC issues with the stakeholders.
• Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements, deploys technical content, assess risks and develops contingency proposals. Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.
• Oversee the authoring and review of CMC documentation, coordination and management of regional submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
• Represents the Regulatory Affairs function as appropriate within the Self Care Franchise.
• Provide regulatory support to policy, external engagement, and issue management within the Need State of responsibility and participate in process, simplification & culture-building activities within own team and across enterprise as required.
• Co-responsible for supporting alignment of key processes, ways of working and simplifications across the Regional Regulatory Self Care team.
• Responsible for meeting compliance requirements within team such as SOP trainings, audits etc.
• Partner with other critical functions to execute plans to address crises and other sensitive issues.
Essential duties and responsibilities
• Serves as a CMC lead for the deployment of CMC regulatory technical content, submissions and compliance activities for Self Care medicinal products supporting.
• Provides and supports technical and operational CMC regulatory direction and documentation for assigned projects/products covering post approval activities.
• Lead the preparation of CMC information for submission to regional regulatory agencies, generates and deploys CMC technical content, assesses risks and develops contingency/mitigation plans.
• Acts as the regional CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of implications for technical CMC decisions.
• Primary accountable for assigned CMC programs, managing daily delivery of regulatory and technical activities, including post-approval changes, and ongoing compliance of commercial products in the portfolio.
• May represent CMC during interactions with internal and external partners either directly or in conjunction with Global/ EMEA Regulatory Affairs Teams.
• Resolve issues and manage regulatory risks within project teams. Investigates opportunities for regulatory improvement / promote the use of novel approaches within project team to resolve issues and problems.
Other features of the job
• Represents Regulatory Affairs on cross-functional product/project teams and provides CMC advice.
• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
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