CMC Specialist

Mcneil Ab; United States; Hybrid; USD 93,000 - 132,000; Full time

Job summary

Kenvue is seeking a CMC Specialist for the Regulatory Affairs team in Reading, United Kingdom. This hybrid role involves acting as the CMC lead within cross-functional project teams, developing regulatory-technical content and supporting regional submissions.

You will review proposed CMC changes, assess regulatory requirements, manage post-approval activities, and ensure ongoing compliance of Self Care medicinal products across the portfolio.

Qualifications

• Experience leading CMC regulatory content deployment.
• Preparation of CMC information for regulatory submissions.
• Coordination of regional submissions and post-approval activities.

Responsibilities

• Act as the CMC lead in cross-functional project teams and ensure regulatory compliance for Self Care products.
• Review and interpret CMC regulatory requirements and prepare robust technical content.
• Lead regional submission activities and manage change control, risk assessment, and contingency plans.
• Represent CMC within the Regulatory Affairs function and support process improvements across teams.

Skills

CMC knowledge

Regulatory collaboration

Cross-functional teamwork

Documentation review

Job description

Kenvue is currently recruiting for a:

CMC Specialist

What we do

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® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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. For more information , click here .

Role reports to: Senior CMC Manager

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

Work Location: Hybrid

What you will do

• - 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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.