Regulatory Affairs Application Support (DocuBridge, CARA) Top Pharma

Compliance Services - Frankfurt, Basel, United States

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About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

About us
Open Position

Tasks and responsibilities

For one of our key clients, one of the most sought-after pharma companies, we are looking for a Regulatory Affairs Application Support to

  • Provide application support to key users for the eDMS, RIMS and eSM platforms (e.g., business functional operations, high-level data analytics, data management, change management)

  • Work with IT and external vendors to troubleshoot technical issues and coordinate system updates

  • Support system data management activities, e.g. master data management, data quality, security and integrity, preparation and implementation of data-related changes

  • Technically support between the handling of operative master data, operative business units and regulatory units

  • Create and maintain all User Requirement Specifications and Quality Control documents as required by SOPs and Processes

  • Analyse, manage, and align on solution releases e.g. process and data requirements, as well as the design, tests scripts authoring and execution

  • Lead business operations impact assessments and industry best practices implementation

  • Federate the user community proactively engaging on new regulatory changes being implemented in the eDMS, RIMS and eSM systems

  • Lead business operations impact assessments and other industry best practices


Your profile

  • Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science)

  • Knowledge of systems in the Regulatory Affairs domain, incl. Regulatory Information Management, electronic Document Management and Publishing Management systems with demonstrated experience in managing support and demand needs for these systems

  • Extensive knowledge of Regulatory Affairs (GRA) business domain and GRA business processes & data management

  • Ideally experience with at least one of the following applications:

  • DocuBridge

  • CARA

  • Veeva Vault

  • TIBCO Spotfire GxP

  • TIBCO Exploratory

  • SAS

  • Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions

  • Familiar with regulatory data standards - IDMP/XEVMPD

  • Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions

  • Some working experience in the Regulatory Affairs area might be beneficial

  • Intrinsic motivation to making healthcare better around the globe


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