Regulatory Data Coordinator, Sr. Manager (Suba)

Regulatory Data Coordinator, Senior Manager

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 Manager:
- Develops ideas and leads/co-leads complex projects across RIO, G&IPE; & GRS.
- Develops and manages plans to achieve objectives
- Applies skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit
- Makes decisions that require developing innovative options to resolve complex problems
- Makes decisions within general business line or functional guide
- Leads operational team(s) within and across Work Teams and Departments
- Involvement in visible and timebound complex and/or high volume projects with pan regional impact with challenging constraints.
- Management of all related RIM events and their relate Postúlate en Kit Empleo: kitempleo.com.co/empleo/1acgvn