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

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

Professional | Permanent | Full-/ Part-time | Hybrid

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve.

You’ll work with talented colleagues in a
-
-
- art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain.

What The Job Looks Like

• 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.
• 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 (Business Process Team, IT Solution Architects, Software Vendors)
• Responsible for gathering, analysis and documentation of new and emerging requirements
• 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
  - ordination of the change implementation (Veeva Vault RIM and other GRA digital solutions
• Responsible for updating user acceptance test scripts and / or performs user acceptance testing for digital product releases
• Investigate reported functional issues to identify solution pathways in close collaboration with relevant stakeholders and SMEs (Business Process Team, IT Solution Architects, Software Vendors)
• Represent Grünenthal in external product communities to bring shared experience and value back to Grünenthal

What You'll Bring To The Table

• 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, x
  EVMPD)
• 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
  - driven and
  - focused environment
• Excellent communication and presentation skills in English
• Attention to details, can do attitude and a positive and proactive mindset
• Excellent team collaboration skills, with the ability to work independently when required