Regulatory Affairs Consultant

Oversees global regulatory master data management operations, ensuring data quality, compliance, and adherence to MDM standards within RIM systems.

The role 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 the individual enables operational excellence and continuous improvement across regulatory data management processes

Key Responsibilities

• The resource should be understand & communicate with colleagues at least in basic English as when required
• The resource should have full command on the local languages such as German
• Responsible for guiding the entry, updating, maintenance, and archival of data entry/correction requests from RIM system users globally
• These resources will support the migration and validation of documents stored outside centralized systems and other repositories identified by client environment.
• The resource should be able to identify the local documents in repository & support the migration team and update the meta data fields as required
• Helps establish MDM standards to enable the transfer of information from data entry request forms into the established systems
• Ensures sustained data quality & support identifying the local documents and update the meta data in Vault.
• 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
• 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
• Assists 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

Skills

• Experience in developing and maintaining data management standards for regulatory systems preferably working with Veeva application.
• 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 – mainly with respect Local languages & support for data clean up & migration process.
• 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 supporting and working with tools and systems used in the Regulatory Affairs environment (Veeva)
• Developing standards
• Expertise in regulatory and data reporting systems and MS Excel
• #J-18808-Ljbffr