Director, CMC Regulatory Processes and Systems

Jobtailor

Greater London

On-site

GBP 120,000 - 180,000

Full time

14 days+

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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

Map processes, systems, and tools used for regulatory CMC activities from early development through lifecycle management
Deliver and implement simplified, robust end-to-end processes with stakeholders and document them through guides or procedures
Collaborate with Regulatory Operations to enhance Veeva RIM/eDMS capabilities and streamline regulatory CMC processes
Develop reporting mechanisms covering compliance status, risks, and system performance
Use data analytics and reporting tools to track compliance metrics and generate actionable insights
Establish processes, systems, and metrics to identify source documents, monitor deliverables, track dossier readiness, submissions, approvals, launches, and implementation changes
Lead sustainable improvement systems and tools and promote a culture of continuous improvement
Establish tools for clinical trial applications, marketing applications, and post-approval activities
Maintain the regulatory CMC strategic plan across assets and identify synergies or conflicts
Create visibility and reporting on team activities
Build and maintain a platform capturing intercontinental CMC submission requirements and communicate them to stakeholders
Coordinate Regulatory CMC Intelligence activities, including regulatory comment consolidation and coordination
Establish working groups to capture future regulatory requirements in ways of working
Ensure systems, tools, and interfaces support effective collaboration with stakeholders
Support budget and resource planning
Establish and maintain the team training matrix
Lead or participate in projects improving efficiency, effectiveness, compliance, and costs
Create, share, and maintain standard dossier section templates
Coach and mentor team members on continuous improvement skills and projects
Extract and digitalize data practices for business use
Monitor industry trends and regulatory changes and adjust processes and systems proactively

Requirements

Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or 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
Strong business acumen
Experience with eDMS systems for regulated environments
Strong ownership and cross-boundary working mindset
Strong analytical and problem-solving capability
Strong ability to lobby, influence, and negotiate
Strong ability to map and define end-to-end processes
Continuous improvement mindset
Strong written, verbal, and interpersonal communication skills
Ability to deal with people at all levels across all functions in a global environment
Self-motivated, curious, willing to challenge, and able to support cross-functional teams
Strong leadership and team management skills, with ability to inspire and motivate diverse teams and drive cultural change
Fluent in English
Strong understanding of global regulatory requirements and compliance standards
Proficient in advanced analytics, IT business systems, and data management
Strong interest in Artificial Intelligence and new technology
Strong automatization and digitalization technical skills
Ability to use standard project management tools
Proficient in Veeva Vault RIM and other regulatory systems
Proficient in Microsoft Office, Teams, SharePoint, MS Project, Power BI, and Visio

Core Competencies

Demonstrates expertise in regulatory CMC processes, including strategic planning, compliance reporting, and data management. Proficient in utilizing advanced analytics and regulatory systems to drive continuous improvement and effective collaboration across global teams.

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