WHAT WE DO

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

WHO WE ARE

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.

WHO WE ARE

At Kenvue, we realise the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.

Experience Required

• Relevant Bachelor’s Degree or higher
• Sound knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
• Sufficient level of knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage forms in addition to manufacturing and regulatory data requirements for managing Global post approval submissions.
• Knowledge in retrieving information from company’s and regulatory agency databases.
• Good level of knowledge on general standards, processes and policies around manufacturing medicinal products.
• Proficiency in Englis

WHAT YOU WILL DO

Job Description
Kenvue is currently recruiting for a:

WHAT YOU WILL DO

The Senior 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 global/regional (as relevant) 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.
• Oversees the authoring and review of CMC documentation, coordination and management of global 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 Global and 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.
• 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 global CMC regulatory direction and documentation for assigned projects/products covering post approval activities.
• Lead the preparation of CMC information for submission to global regulatory agencies, generates and deploys CMC technical content, assesses risks and develops contingency/mitigation plans.
• Acts as the global/regional CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global 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 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.

Experience Required

• Relevant Bachelor’s Degree or higher
• Sound knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
• Sufficient level of knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage forms in addition to manufacturing and regulatory data requirements for managing Global post approval submissions.
• Knowledge in retrieving information from company’s and regulatory agency databases.
• Good level of knowledge on general standards, processes and policies around manufacturing medicinal products.
• Proficiency in English