Overview
Senior CMC Specialist (Self Care) at Kenvue – High Wycombe, England, United Kingdom. Hybrid work location; planned office move to Reading, Berkshire in Q1 2026. Role reports to the Director, Regulatory Affairs, Self Care Lead.
Location: Europe/Middle East/Africa, United Kingdom, England, High Wycombe. Work Location: Hybrid.
Responsibilities
* Acts as the global/regional CMC representative within cross-functional project teams. Accountable for assigned projects and activities, completing work within the 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.
* 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 the team such as SOP trainings, audits, etc.
* Partners with other critical functions to execute plans to address crises and other sensitive issues.
* Serves as a CMC lead for deployment of regulatory technical content, submissions and compliance activities for Self Care medicinal products.
* Provides and supports technical and operational global CMC regulatory direction and documentation for assigned projects/products (post-approval activities).
* Leads 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, interpreting regulations and guidelines and assessing 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 with Global Regulatory Affairs Teams.
* Resolves issues and manages regulatory risks within project teams; investigates opportunities for regulatory improvement and promotes the use of novel approaches to resolve issues.
Experience Required
* Relevant Bachelor's Degree or higher
* Sound knowledge in the regulatory requirements of post-approval changes for global markets including ICH guidance
* Knowledge of post-approval changes for solid oral, nasal spray and other dosage forms, plus manufacturing and regulatory data requirements for global submissions
* Knowledge in retrieving information from company and regulatory agency databases
* Good knowledge of general standards, processes and policies around manufacturing medicinal products
* Proficiency in English
What We Are Looking For
* Excellent communication skills, clear and persuasive ability to convey regulatory or technical issues
* Strong interpersonal skills and ability to build networks internally and externally
* Highly collaborative with a strong sense of ownership and accountability
* Strong organizational and time management skills; able to work under pressure
* Demonstrable commercial focus and business acumen in a fast-paced environment
* In-depth knowledge of regulatory affairs, cross-functional partners, and the ability to influence decisions
* Able to work effectively in a multi-cultural, highly matrixed organization
What’s In It For You
* Competitive Benefit Package
* Paid Company Holidays, Paid Vacation, Volunteer Time & More
* Learning & Development Opportunities
* Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to 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. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Legal
Industries
* Personal Care Product Manufacturing
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