Regulatory Data Support Specialist

Smartedges Client is looking for an individual to help with their in Sr. Specialist (Data Support End User Expert – Veeva RIM) _ Contract _Remote (EU)
Job Description:
The Sr. Specialist, Data Support End User Expert, is responsible for overseeing global regulatory master data management operations, ensuring data quality, compliance, and adherence to MDM standards within RIM systems. The role leads and supports the data management team, drives process improvements, manages client relationships and governance activities, and develops reporting metrics to ensure timely, accurate, and high-quality service delivery. Leveraging expertise in Regulatory Affairs systems, data governance, reporting, and Six Sigma methodologies, the individual enables operational excellence and continuous improvement across regulatory data management processes.
Support Veeva Active Dossier Management by performing:
Dossier Lifecycle Oversight: Maintain a holistic, cross-market view of current, submitted, and superseded product documents using Veeva Vault Active Dossier.
Data & Process Automation: Oversee automated generation and calculation of dossier records linked to regional submissions, global content plans, and health authority interactions
Configuration & Maintenance: Manage Active Dossier templates, object lifecycles, and country-level generation rules within Veeva Vault.
Cross-Functional Support: Partner with regulatory authors, CMC teams, and submission managers to verify traceability and resolve document-type discrepancies.
Audit & Compliance Readiness: Ensure accurate tracking of local-language translations, source files, and status history across various international markets.
Key Responsibilities:
Responsible for guiding the entry, updating, maintenance, and archival of data entry/correction requests from RIM system users globally
Helps establish MDM standards to enable the transfer of information from data entry request forms into the established systems
Ensures sustained data quality
Acts as the liaison to client management for all process-related items
Escalates issues and concerns from team members
Conveys feedback from the client to team members
Responsible for establishing and providing oversight to the data management team, ensuring that:
- Team members are trained appropriately and understand their roles
- Service levels are met
- All deliverables are produced according to the process and within the agreed timelines
Assist in identifying process improvement areas
Participates in governance meetings with the client regularly
Works with the client to develop a clear and detailed plan for reporting metrics
Required Skills & Experience:
Experience in developing and maintaining master data management standards for regulatory systems
Ability to handle transactions in line with the established procedures and policies
Ability to handle project operations
Ability to protect confidential information
Strong capacity to work within deadlines
Ability to perform the assigned tasks swiftly and accurately
Detail oriented
Outstanding skills in customer service delivery
Demonstrated problem-solving skills
Proven experience in analyzing information in support of data management activities
Managing processes and ensuring staff compliance
Experience in Six Sigma methodology
Experience in supporting and working with tools and systems used in the Regulatory Affairs environment
Developing standards
Reporting skills
Expertise in regulatory and data reporting systems and MS Excel
Key Requirements:
Experience in pharmaceutical, biotechnology, or medical device organizations operating globally. Bachelor’s degree required.
Experience leading data governance, master data management, process improvement, or transformation initiatives.
Familiarity with reporting, analytics, and data visualization tools.
Connect with my Colleague or email my Colleague at pavithradevi.r@smartedgesolutions.co.uk
(OR)
Contact via +44 (0) 203813196

Work arrangement
Yes