Regulatory Data Coordinator (Bogotá)

Regulatory Data Coordinator (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.​
The Regulatory Data Coordinator is responsible for driving key & critical activities within the Pfizer RIM system 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 General 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:
- Manage all RIM events and related records, including event and registration details, ensuring structures and relationships accurately reflect product market registrations, align with master data standards, and remain updated in accordance with health authority decisions.
- Interpret health authority communications, drive appropriate system updates, notify stakeholders as needed, and collaborate with GRS stakeholders, CMC strategists, PGS, and cross-functional teams to understand and fulfill data requirements.
- Review and approve data change requests, ensuring compliance with data governance standards, policies, and regulatory requirements.
- Maintain active dossiers throughout the product lifecycle, ensuring ongoing

📌 Regulatory Data Coordinator (Bogotá)
🏢 Pfizer
📍 Bogotá

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: regulatory data coordinator (bogotá) / bogotá

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: regulatory data coordinator (bogotá) / bogotá