CMC Specialist

CMC Specialist

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Senior CMC Manager

Ubicazione:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Luogo di lavoro:

Ibrido

Cosa farai

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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