Senior CMC Specialist (Self Care)

Kenvue; High Wycombe; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company at the forefront of science as a Senior CMC Specialist. In this dynamic role, you'll lead the Life Cycle Management of products within the Self Care franchise, providing regulatory assessments and technical guidance. Collaborate with diverse teams to ensure compliance and drive innovative solutions in a multi-cultural environment. This is an exciting opportunity to make a significant impact on the lives of millions while working with iconic brands. If you are passionate about regulatory affairs and eager to shape the future of everyday care, this position is for you.

Qualifications

• Bachelor's Degree or higher in a relevant field required.
• Knowledge of post-approval changes regulations for global markets.

Responsibilities

• Lead CMC regulatory technical content and compliance activities.
• Manage regulatory submissions and ensure product compliance.
• Collaborate with cross-functional teams on regulatory issues.

Skills

Regulatory Knowledge

Communication Skills

Interpersonal Skills

Project Management

Analytical Skills

Education

Bachelor's Degree in a relevant field

Tools

Regulatory Agency Databases

Job description

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.

Job Description - Senior CMC Specialist (Self Care) (2507034048W)

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 the lives of millions of people every day. We put people first, care fiercely, earn trust with science, solve with courage, and offer brilliant opportunities. 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. The role involves providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.

• Acts as the global/regional CMC representative within cross-functional project teams. Accountable for assigned projects and activities, ensuring work is completed 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, manages global submissions, assesses and manages commercial license status, maintains product compliance, and manages change control.
• Represents Regulatory Affairs within the Self Care Franchise as appropriate.
• Provides regulatory support for 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.
• 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 CMC representative within 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.
• May represent CMC during interactions with internal and external partners.
• Resolves issues and manages regulatory risks within project teams, promoting regulatory improvements and innovative approaches.

Qualifications

Essential Skills and Knowledge

• Bachelor's Degree or higher in a relevant field
• Knowledge of post-approval changes regulations for global markets, including ICH guidance
• Experience handling post-approval changes for 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 standards, processes, and policies around medicinal product manufacturing

Core Competencies

Excellent communication skills, interpersonal skills, collaboration, organizational and time management skills, business acumen, and proficiency in English. Ability to work effectively in a multi-cultural, matrixed organization and to build effective relationships internally and externally.

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 without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, veteran status, disability, or other protected status.