Senior CMC Specialist (Self Care)
Description
This position is based at our High Wycombe office (hybrid working policy).
Kenvue have announced a planned move of offices to Reading, Berkshire in Q1 of 2026.
Please note that this role will move locations along with this office move.
We have more then one position for this role.
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.
Job Purpose
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 crise...
- Rate: Not Specified
- Location: High Wycombe, GB-BKM
- Type: Permanent
- Industry: Finance
- Recruiter: Kenvue Brands LLC
- Contact: Not Specified
- Email: to view click here
- Reference: 2507034048W
- Posted: 2025-04-30 08:14:08 -
- View all Jobs from Kenvue Brands LLC
More Jobs from Kenvue Brands LLC
- Postbote für Pakete und Briefe – Aushilfe (m/w/d)
- Postbote für Pakete und Briefe (m/w/d)/ Minijob/Aushilfe/Abrufkraft in 01609 Gröditz
- Postbote für Pakete und Briefe (m/w/d)/ Minijob/ Aushilfe/Abrufkraft in 01689 Weinböhla
- Postbote für Pakete und Briefe (m/w/d)/ Minijob/Aushilfe/Abrufkraft, 01558 Großenhain
- Postbote für Pakete und Briefe – Aushilfe (m/w/d)
- Postbote für Pakete und Briefe – Aushilfe (m/w/d)
- Postbote für Pakete und Briefe – Aushilfe (m/w/d)
- Postbote für Pakete und Briefe – Aushilfe (m/w/d)
- Postbote / Zusteller / Kurier für Pakete und Briefe (m/w/d)
- Automation Platform Technician
- Automation Platform Technician
- Optical Test Engineer - Optical Solutions
- Postbote für Pakete und Briefe (m/w/d)
- Postbote – Minijob / Aushilfe (m/w/d)
- Optical System Test Engineer
- Human Resource Business Partner
- Operations Technician
- Postbote für Pakete und Briefe (m/w/d)
- Chemical Process Safety Engineer
- Accounting Assistant