Director, CMC Regulatory Processes and Systems

Ipsen

CMC regulatory systems director advancing digital processes, analytics, and compliance for Ipsen, a global biopharmaceutical company developing transformative medicines. Leading process improvement across regulatory submissions and lifecycle management.

Posted 8/25/2026full-timeLondon • 🇬🇧 United KingdomLeadWebsite

Core Competencies

Role fit

Core Competencies

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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.

Highest-signal resume keywords

Regulatory CMC ExperienceVeeva Vault RIM ProficiencyData Management ExpertiseContinuous Improvement MindsetStrong Leadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ProcessesRegulatory SubmissionsStrategic PlanningData AnalyticsProcess MappingCompliance ReportingAutomation SkillsDigitalization SkillsIT Business SystemsAdvanced Analytics

Soft Skills

Strong Communication SkillsAnalytical Problem-SolvingInfluencing and NegotiationCross-Functional CollaborationTeam Management

Tools & Technologies

Veeva Vault RIMEDMS SystemsMicrosoft OfficePower BIMS ProjectSharePointVisioTeams

Industry Keywords

Pharmaceutical CMCRegulatory ComplianceGlobal Regulatory RequirementsClinical Trial ApplicationsMarketing Applications

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Inclusive workplace committed to diversity, equity, and equal opportunities
Application adjustments or support available during the recruitment process
Global workplace with opportunities to collaborate across more than 40 countries
Coaching and mentoring opportunities for team members