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Job Description - Senior CMC Specialist (Self Care) (2507034048W)
Senior CMC Specialist (Self Care) - 2507034048W
Description
This position is based at our High Wycombe office (hybrid working policy). Kenvue has 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 than one position for this role.
Who We Are
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. Science is our passion; care is our talent. Our global team of 22,000 diverse and brilliant people is passionate about insights, innovation, and committed to delivering the best products to our customers. Being a Kenvuer means having the power to impact millions of lives every day. We put people first, care fiercely, earn trust with science, and solve with courage. 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. They will provide 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 the assigned product portfolio. Develops resolution proposals for regulatory CMC issues with stakeholders.
* Reviews proposed CMC changes for completeness and accuracy, interprets CMC regulatory requirements, deploys technical content, assesses risks, and develops contingency proposals. Uses technical and scientific knowledge to analyze CMC submission documentation.
* Oversees the authoring and review of CMC documentation, coordination, and management of global submissions, including 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.
* Provides regulatory support to policy, external engagement, and issue management within the Need State of responsibility. Participates in process, simplification, and culture-building activities within the team and across the enterprise as required.
* Supports alignment of key processes, ways of working, and simplifications across the Global and Regional Regulatory Self Care team.
* Ensures compliance with team requirements such as SOP trainings and audits.
* Partners with other functions to execute plans addressing crises and sensitive issues.
Essential duties and responsibilities
* Serves as a CMC lead for deploying regulatory technical content, submissions, and compliance activities for Self Care medicinal products.
* Provides technical and operational global CMC regulatory direction and documentation for post-approval activities.
* Prepares CMC information for submission to global regulatory agencies, generates and deploys technical content, assesses risks, and develops mitigation plans.
* Acts as the global/regional CMC representative in cross-functional project teams, interpreting regulations and assessing global implications for technical decisions.
* Manages daily delivery of regulatory and technical activities for assigned CMC programs, including post-approval changes and ongoing compliance.
* Represents CMC during interactions with internal and external partners, directly or with Global Regulatory Affairs Teams.
* Resolves issues and manages regulatory risks within project teams. Investigates opportunities for regulatory improvements and promotes novel approaches.
Qualifications
Essential Skills and Knowledge
* Bachelor's Degree or higher in a relevant field
* Knowledge of post-approval change regulations for global markets, including ICH guidance
* Experience handling post-approval changes of solid oral, nasal sprays, and other dosage forms, including manufacturing and regulatory data requirements
* Ability to retrieve information from company and regulatory agency databases
* Understanding of manufacturing standards, processes, and policies for medicinal products
Core Competencies
* Excellent communication skills, able to articulate complex regulatory or technical issues clearly and persuasively
* Strong interpersonal skills for building effective networks internally and externally
* Highly collaborative with a strong sense of ownership and accountability
* Strong organizational and time management skills, capable of working under pressure
* Business acumen and commercial focus to thrive in a fast-paced environment
* In-depth knowledge of business, organizational goals, and Regulatory Affairs functions
* Ability to work effectively in a multicultural, matrixed organization
* Proficiency in English
Primary Location
Europe/Middle East/Africa - United Kingdom - England - High Wycombe
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
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