CMC Specialist

CMC Specialist

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Senior CMC Manager

Locatie:

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

Werklocatie:

Hybride

Wat je gaat doen

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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