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
About Accenture
Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services-creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.
Visit us at www.accenture.com
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