Pharma Regulatory IT Specialist - Data Governance (Remote)

Aequor Consulting GmbH; Basel; On-site; CHF 120,000 - 160,000; Full time

Benefits offered by this job

Remote Job

5 weeks of annual leave

Coverage of certification costs

Reka-Card with 20% discount on up to 2

CHF 400 contribution towards fitness

Job summary

Unknown client in pharmaceutical IT seeks a technically skilled professional with proven TRD Composer experience and regulatory data management expertise. The role focuses on integrating regulatory IT systems, governing data, and coordinating cross-functional activities in a highly regulated environment.

You will drive interfaces between GSRS and TRD Composer, create substance data models, and lead data governance initiatives while aligning IT changes with regulatory requirements.

Qualifications

• Proven hands-on experience with TRD Composer and its purpose, design and functionality.
• Experience with regulatory processes and GMP-type documentation in pharma.
• Knowledge of IDMP and ISO standards in digital regulatory workflows.
• Understanding of IT systems, interfaces, data models and data governance.
• Experience with pharmaceutical substance data; GSRS familiarity is a plus.
• Knowledge of IT documentation and change management in regulated pharma.
• Strong English communication, coordination and leadership capabilities.

Responsibilities

• Coordinate SUAM 3.0 implementation into TRD Composer with NVS IT Production.
• Set up GSRS and develop interfaces between GSRS and TRD Composer for substance data exchange.
• Create and maintain TRD reference data model for substances.
• Coordinate TRD Data Governance organization and data management processes.
• Coordinate technical implementations and system changes with IT and business stakeholders.
• Support change management activities in line with IT documentation and processes.
• Ensure alignment between technical requirements and regulatory documentation needs.

Skills

TRD Composer

Regulatory documentation

Data governance

IT systems

Interfaces & data models

Stakeholder coordination

Leadership

Tools

GSRS

Job description

Unknown client in pharmaceutical IT seeks a technically skilled professional with proven TRD Composer experience and regulatory data management expertise. The role focuses on integrating regulatory IT systems, governing data, and coordinating cross-functional activities in a highly regulated environment.

You will drive interfaces between GSRS and TRD Composer, create substance data models, and lead data governance initiatives while aligning IT changes with regulatory requirements.