Strategic Lead, Regulatory CMC Processes & Systems

Jobtailor; Greater London; On-site; GBP 120,000 - 180,000; Full time

Job summary

Jobtailor in Greater London is seeking a Senior Regulatory CMC Manager to lead end-to-end regulatory data processes across global assets and lifecycle programs. You will collaborate with Regulatory Operations and IT to optimize Veeva Vault RIM and eDMS, implement robust reporting, and drive improvement through analytics.

The ideal candidate has 10+ years in pharmaceutical CMC, fluent English, and a proven record of delivering compliant submissions and cross-functional leadership.

Qualifications

• Advanced degree in Life Sciences, IT, Regulatory Affairs, or a related field.
• Minimum 10 years’ experience in pharmaceutical CMC environment.
• Experience in regulatory processes, regulatory submissions, and approvals.
• Experience in strategic planning, execution, and reporting of regulatory data.
• Experience transforming organizations and ways of working.
• Experience overseeing IT business systems and data management.

Responsibilities

• Map processes, systems, and tools used for regulatory CMC activities across development lifecycles.
• Deliver robust end-to-end processes with stakeholders and document them via guides or procedures.
• Collaborate to enhance Veeva Vault RIM/eDMS capabilities and streamline CMC processes.
• Develop reporting mechanisms covering compliance status, risks, and system performance.
• Use data analytics and reporting tools to track compliance metrics and generate insights.
• Establish and monitor source documents, dossier readiness, submissions, approvals, launches, and changes.
• Lead continuous improvement initiatives and tool adoption across the team.
• Create visibility and reporting on team activities.
• Coordinate Regulatory CMC Intelligence activities, including regulatory comment consolidation.

Education

Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or related field

Tools

Veeva Vault RIM

EDMS Systems

Power BI

MS Project

SharePoint

Visio

Teams

Job description

Jobtailor in Greater London is seeking a Senior Regulatory CMC Manager to lead end-to-end regulatory data processes across global assets and lifecycle programs. You will collaborate with Regulatory Operations and IT to optimize Veeva Vault RIM and eDMS, implement robust reporting, and drive improvement through analytics.

The ideal candidate has 10+ years in pharmaceutical CMC, fluent English, and a proven record of delivering compliant submissions and cross-functional leadership.