Regulatory Affairs Digital Product Champion (m/f/d)

Grünenthal Group
Maidenhead
4 months ago
Applications closed

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Regulatory Affairs Digital Product Champion (m/f/d)

Join to apply for the Regulatory Affairs Digital Product Champion (m/f/d) role at Grünenthal Group.


What The Job Looks Like

Each day you'll enjoy a variety of challenges, such as:



  • Champion and provide functional expertise with usage of Vault RIM suite – ERON (Registrations, Submissions, Submissions Archive & Publishing) to Global Regulatory Affairs and its enterprise stakeholders. This includes but not limited to supporting business users with:
  • Best practices and agreed usage of Vault RIM system functionality
  • Understanding of data model and object relationship within ERON
  • Understanding of implemented data standards and operating model within ERON
  • Understanding of business process, roles and responsibilities (security model) implemented within ERON
  • Lead and support successful adoption of ERON across business functions
  • Support development and maintenance of change management and training artefacts – user guides, best practices, videos, etc.
  • Provide training and change management support for continuous adoption and desired usage of the system functionality
  • Track and maintain business requirements (user requirements and user stories) implemented and its traceability to system functionality and business process, in close collaboration with relevant stakeholders and SMEs
  • Analyze new and emerging requirements to identify solution pathways in close collaboration with relevant stakeholders and SMEs (Business & IT Teams)
  • Support quarterly release impact assessment, planning and co-ordination of the change implementation (Veeva Vault RIM and other GRA digital solutions)
  • Responsible for updating user acceptance test scripts and/or performing user acceptance testing for digital product releases
  • Investigate reported functional issues to identify solution pathways in close collaboration with relevant stakeholders and SMEs
  • Represent Grünenthal in external product communities to bring shared experience and value back to Grünenthal

What You'll Bring To The Table

To make the most of this role and truly thrive, you should have:



  • University degree in Life Sciences, Regulatory Affairs, Systems and Data Management, or Business Administration
  • Expert level understanding and 5+ years working experience with Veeva Vault RIM Suite (Registrations, Submissions, Submissions Archive, Publishing)
  • Deep expertise and 10+ years of experience with Regulatory Information Management processes
  • Strong understanding & working experience of structured data submissions (IDMP, SPOR, xEVMPD)
  • Considerable understanding and 6+ years working experience with regulatory affairs processes supporting lifecycle maintenance of marketed products in the EU & US
  • Veeva certified professionals preferred
  • Ability to manage multiple tasks simultaneously in a results-driven and customer-focused environment
  • Excellent communication and presentation skills in English
  • Attention to detail, can-do attitude and a positive and proactive mindset
  • Excellent team collaboration skills, with the ability to work independently when required


"Join us if you are solution oriented, champion at problem solving and want to make a meaningful impact by driving digital change and adoption supporting Global Regulatory Affairs and its enterprise stakeholders."


Argha Nag, the Hiring Manager



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