Global CMC Specialist - Regulatory Lifecycle Leader

Kenvue; Reading; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

Kenvue is seeking a CMC Specialist to lead lifecycle management and regulatory content for Self Care medicines across the EMEA region and globally where relevant. You will provide regulatory input to product development teams, helping ensure CMC requirements are met and changes are managed effectively.

The role requires collaboration with cross-functional partners, overseeing documentation, and coordinating regional submissions to maintain compliance and support regulatory milestones.

Responsibilities

• Acts as the CMC representative within cross-functional project teams.
• Reviews proposed CMC changes for completeness and accuracy; interprets regulatory requirements.
• Oversee the authoring and review of CMC documentation, coordination and management of regional submissions.
• 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.

Job description

Kenvue is seeking a CMC Specialist to lead lifecycle management and regulatory content for Self Care medicines across the EMEA region and globally where relevant. You will provide regulatory input to product development teams, helping ensure CMC requirements are met and changes are managed effectively.

The role requires collaboration with cross-functional partners, overseeing documentation, and coordinating regional submissions to maintain compliance and support regulatory milestones.