Regulatory Data Coordinator, Senior Associate (Suba)

Regulatory Data Coordinator, Senior Associate

Job Summary

Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted.

The Regulatory Data Coordinator is responsible for driving key & critical activities within V-RIM in support of enabling the assessment and subsequent management of new or required changes (system events).

They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items & Label Concepts are associated and have the appropriate details as well as creating the Integral Content Plan in readiness for content authoring across the enterprise.

The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical & Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licences & master data as well as the end-to-end regulatory change management experience within & across domains.

Job Responsibilities

Senior Associate:
- Contributes to the completion of moderately complex projects
- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team
- Applies skills and discipline knowledge to contribute to the achievement of work within Work Team
- Makes decisions to resolve moderately complex problems in standard situations
- Makes decisions within guidelines and policies
- Participates and contributes as a team member
- Management of all related RIM events and their related records, including event details and registered details
- ensuring structures and relationships enable accu Postúlate en Kit Empleo: kitempleo.com.co/empleo/1acgva