Regulatory Data Steward (Bogotá)

Regulatory Data Steward (Bogotá)

10 ago
|
Pfizer
|
Bogotá

10 ago

Pfizer

Bogotá

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.​
Master data is crucial for regulatory & Pfizer because it ensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes. Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties. The Regulatory Data Steward is accountable for the creation and maintenance of Pfizer’s RIM System Master Data on behalf of the organization.
They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical,



RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed.
The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level.
A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Integral Regulatory Sciences.
Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital.

Job responsibilities as a senior manager:
- Generate & Maintain Regulatory & Enterprise Master Data: Accountable for leading the accurate definition & recordin

📌 Regulatory Data Steward (Bogotá)
🏢 Pfizer
📍 Bogotá

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