We are seeking an experienced Business Process Lead to support and lead Regulatory Information Management (RIM) transformation programmes within the Life Sciences industry. The role will focus on driving end-to-end regulatory business process design, process harmonisation, and implementation readiness as part of large-scale Veeva Vault RIM implementations.
The successful candidate will combine strong regulatory domain expertise with consulting, stakeholder management, and delivery leadership capabilities to support global transformation programmes across Regulatory Affairs organisations.
Key Responsibilities
Lead regulatory business process workstreams within Veeva Vault RIM implementations
Facilitate and lead global workshops with business and IT stakeholders across Regulatory Affairs functions
Drive future-state process design, process mapping, gap assessments, and requirements definition
Translate business requirements into user stories, functional requirements, acceptance criteria, and process documentation
Support configuration discussions and alignment between business, architecture, integration, and development teams
Support implementation planning, business readiness, change management, and adoption activities
Work closely with migration, testing, validation, and integration teams to ensure alignment across workstreams
Support governance, RAID management, status reporting, and executive stakeholder communications
Contribute to proposal development, solution shaping, effort estimation, and client presentations
Support agile delivery methodologies including SAFe, Scrum, and sprint-based execution models
Required Skills & Experience
8+ years of experience within Life Sciences, Regulatory Affairs, or Pharma R&D transformation programmes
Strong experience supporting or leading Veeva Vault RIM implementations
Deep understanding of Regulatory business processes including:
Submission Management
Registration Management
Health Authority Interactions
Regulatory Planning
Product & Application Lifecycle Management
Experience facilitating business process workshops and managing senior stakeholders globally
Experience writing user stories, requirements, process maps, and functional specifications
Strong understanding of regulatory data flows, integrations, and cross-functional dependencies
Experience working within agile delivery environments (SAFe, Scrum, Kanban)
Excellent communication, consulting, and stakeholder management skills
Ability to work across global teams, functions, and time zones
Veeva Vault RIM certification(s)
Experience with Regulatory data strategy, migration, testing, or validation activities
Experience with cloud-based R&D platforms (e.g., Veeva Vault, CTMS, eTMF, Promomats)
Consulting experience within large-scale transformation programmes
Understanding of emerging regulatory requirements and compliance frameworks
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, sexual orientation, gender identity or expression, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
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