Senior Regulatory Data Lead for Submissions & Lifecycle

Pfizer

Bogotá

On-site

COP 189,310,000 - 252,414,000

Full time

6 days ago

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Job summary

Pfizer seeks a Regulatory Data Coordinator to drive critical activities within the Pfizer RIM system, enabling assessment and management of changes across the product lifecycle. You will review events, perform impact assessments, and create records to support regulatory actions, while ensuring data quality and alignment with agency decisions.

You will also maintain metadata, manage Dossiers, and train business users on data governance.

Qualifications

B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology (desirable).
2+ years in regulatory, data management or data governance in pharma/healthcare.
End-to-end regulatory change management experience including HA submissions.
Understanding of regulatory systems and SME processes across lifecycle (IDMP, CMC).
Strong data governance and quality improvement knowledge.
Proven ability to learn new software and comply with standards.

Responsibilities

Review events across product lifecycle and support impact assessments.
Create and manage Activities, Regulatory Objectives and Submissions.
Ensure metadata accuracy and maintain dataset structures aligned to agency decisions.
Provide training and support on data quality standards and processes.
Collaborate with regulatory strategists and stakeholders to mitigate risks.