Head Regulatory Information Management; m​/f​/d

Overview

Professional | Permanent | Full-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.

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

• Delivering high-quality regulatory information management services for Grünenthal, including:
  • RIM Product Championship (functional expertise, change management, training, and adoption of functionalities)
  • RIM Process Management (harmonized, effective, and continuously improved business processes)
  • RIM Data Management (effective, compliant, and aligned data management processes & standards)
  • RIM Lifecycle Management (continuous development of RIMS platforms and adjacent technologies together with IT based on business needs)
  • RIM Operations (high-quality regulatory operation services, including submission publishing)
• Leading the evolution and prioritization of the GRA digital roadmap in close alignment with R&D Digital Transformation Office and IT
• Driving the development of Regulatory Data Management & Governance capabilities aligned with R&D data strategy & governance
• Enabling regulatory data analytics capabilities to maximize data value
• Leading integration of RIMS with cross-functional systems and manages complex data landscapes
• Defining and executing Grünenthal’s regulatory data strategy to ensure compliance with evolving global regulations (e.g. IDMP, ESMP, eCTD 4.0)
• Leading vendor selection, performance management, and external partnerships for GRA digital solutions and operations
• Driving operational efficiency, resource optimization, and budget management for RIM services
• Monitoring digital regulatory trends to ensure global readiness for upcoming requirements
• Representing Grünenthal in external industry forums and engages external experts as needed

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

• University degree in science, technology, or equivalent experience
• 10+ years of experience in regulatory information management within the pharmaceutical industry
• Strong knowledge of RIM processes across development and marketed products (EU & US required; LATAM a plus)
• In-depth understanding of relevant regulatory standards and regulations (e.g. IDMP, xEVMPD, eCTD, ESMP)
• 5+ years of hands-on experience with Veeva Vault RIMS and its business processes
• Experience with multiple RIM technologies and digital trends in Global Regulatory Affairs
• Global regulatory experience with a focus on EU and US
• Proven leadership and people development experience, driving high-performing teams
• Solid experience in budget, vendor, and contract management
• Strong project, people, change, and stakeholder management skills
• Excellent communication, negotiation, and presentation skills
• Strategic mindset with the ability to translate long-term vision into actionable goals
• Ability to work effectively in a matrix organization
• Excellent business English skills