CMC Regulatory Lead – Lifecycle & Submissions (EMEA)

Kenvue; Greater London; Hybrid; GBP 55,000 - 85,000; Full time

Job summary

Kenvue in Reading, UK, is seeking a CMC Specialist to lead regulatory lifecycle activities for Self Care products across the EMEA region and beyond. You will provide regulatory input to product development teams and ensure compliance of CMC documentation.

As a key member of cross-functional teams, you will review CMC changes, manage regional submissions, and support risk mitigation and change control. Hybrid work arrangement and global collaboration with Regulatory Affairs are part of the role.

Qualifications

• Experience leading CMC regulatory activities for medicinal products.
• Ability to interpret regulations and guide product development teams.
• Strong coordination with cross-functional teams and regional submissions.
• Knowledge of post-approval changes and compliance requirements.

Responsibilities

• Acts as the CMC representative within cross-functional project teams.
• Reviews proposed CMC changes for completeness and accuracy.
• Oversee the authoring and review of CMC documentation and regional submissions.
• Represent Regulatory Affairs within the Self Care Franchise.
• Provide regulatory support to policy, external engagement, and issue management.
• Co-responsible for aligning processes within the Regional Regulatory Self Care team.
• Responsible for SOP trainings, audits and compliance.
• Partner with other functions to address crises and other sensitive issues.

Skills

CMC regulatory

Regulatory affairs

Cross-functional teamwork

Regulatory guidance

Risk assessment

Education

Pharma/Regulatory degree

Job description

Kenvue in Reading, UK, is seeking a CMC Specialist to lead regulatory lifecycle activities for Self Care products across the EMEA region and beyond. You will provide regulatory input to product development teams and ensure compliance of CMC documentation.

As a key member of cross-functional teams, you will review CMC changes, manage regional submissions, and support risk mitigation and change control. Hybrid work arrangement and global collaboration with Regulatory Affairs are part of the role.