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

Overview

Regulatory Affairs Digital Product Champion (m/f/d) – Grünenthal Group

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

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 state-of-the-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. Join us today, and discover the difference you can make.

Responsibilities

• 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
• 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
• 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 performs 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

Qualifications

• 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)
• 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

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Science, and Health Care Provider

Industries

• Pharmaceutical Manufacturing
• Hospitals and Health Care
• Biotechnology Research

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